title: A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy

summary: The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.

ReferenceCitation: Durez P, Vandepapeliere P, Miranda P, Toncheva A, Berman A, Kehler T, Mociran E, Fautrel B, Mariette X, Dhellin O, Fanget B, Ouary S, Grouard-Vogel G, Boissier MC. Therapeutic vaccination with TNF-Kinoid in TNF antagonist-resistant rheumatoid arthritis: a phase II randomized, controlled clinical trial. PLoS One. 2014 Dec 17;9(12):e113465. doi: 10.1371/journal.pone.0113465. eCollection 2014.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
PubMed Central
figshare.com

repositories_concat: HAL;PubMed Central;figshare.com

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: Public Library of Science

lead_sponsor: Neovacs

location_country: Argentina Romania Belgium Croatia Chile Bulgaria France

location_facility: Universitaires Cliniques St. Luc (Mont-Godinne)

location_facility: National Multiprofile Transport Hospital "Tzar Boris III"

location_facility: Centro de Investigaciones Reumatologicas

location_facility: University Hospital for Active Treatment "Sveti Ivan Rilski"

location_facility: "Dr. Constantin Opris" Emergency County Hospital Baia Mare

location_facility: Universiteit ZiekenHuis Katholiek Universiteit Leuven

location_facility: Centro de Estudios Reumatológicos- Estudios Clínicos Limitada"

location_facility: Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802

location_facility: "Sociedad Médica del Aparato Locomotor SA"

location_facility: Centro especializado en Investigaciones Medicas (CEIM)

intervention_type: Biological


title: An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection

summary: The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Marty FM, Man CY, van der Horst C, Francois B, Garot D, Manez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study. J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 Aug 27.

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via OAI-PMH title and first author match)

license_normalized: no license

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;g445cn362

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Norway
Hong Kong
United Kingdom
Australia
Brazil
Japan
United States
Spain
Thailand
South Africa
Canada
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: BRIM 3

lead_sponsor: Hoffmann-La Roche

summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.

ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: University of California - eScholarship University of California

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Chapman PB, Robert C, Larkin J, Haanen JB, Ribas A, Hogg D, Hamid O, Ascierto PA, Testori A, Lorigan PC, Dummer R, Sosman JA, Flaherty KT, Chang I, Coleman S, Caro I, Hauschild A, McArthur GA. Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study. Ann Oncol. 2017 Oct 1;28(10):2581-2587. doi: 10.1093/annonc/mdx339.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org;www.zora.uzh.ch

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Yamazaki N, Kiyohara Y, Sugaya N, Uhara H. Phase I/II study of vemurafenib in patients with unresectable or recurrent melanoma with BRAF(V) (600) mutations. J Dermatol. 2015 Jul;42(7):661-6. doi: 10.1111/1346-8138.12873. Epub 2015 Apr 17.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: McArthur GA, Chapman PB, Robert C, Larkin J, Haanen JB, Dummer R, Ribas A, Hogg D, Hamid O, Ascierto PA, Garbe C, Testori A, Maio M, Lorigan P, Lebbe C, Jouary T, Schadendorf D, O'Day SJ, Kirkwood JM, Eggermont AM, Dreno B, Sosman JA, Flaherty KT, Yin M, Caro I, Cheng S, Trunzer K, Hauschild A. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014 Mar;15(3):323-32. doi: 10.1016/S1470-2045(14)70012-9. Epub 2014 Feb 7.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.

ReferenceCitation: Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15. doi: 10.1056/NEJMoa1105358.

ReferenceCitation: Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. doi: 10.1056/NEJMoa1103782. Epub 2011 Jun 5.

title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine

location_country:
Germany
Italy
New Zealand
Israel
United Kingdom
Australia
Sweden
Netherlands
Switzerland
United States
Canada
France


lead_sponsor: Amgen

summary: The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

ReferenceCitation: Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.

oa_host_type: closed

title: A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country:
Germany
Poland
Australia
Serbia
France
Czech Republic
Slovenia
Portugal
Slovakia
Hungary
Denmark
Latvia
Romania
Belgium
Estonia
Italy
United Kingdom
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel


study_start_date_type: Actual

lead_sponsor: Janssen Research & Development, LLC

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

ReferenceCitation: Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sanchez-Iglesias A, di Capua C, Castro E, Ferrer C, Sanchez-Hernandez A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6.

ReferenceCitation: Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: acceptedVersion

repositories_concat: PubMed Central;dash.harvard.edu

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

ReferenceCitation: Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naive metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.

ReferenceCitation: Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.

repositories_institution: University of California - eScholarship University of California

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

ReferenceCitation: Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.

ReferenceCitation: Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

ReferenceCitation: Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

ReferenceCitation: Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.

ReferenceCitation: Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

location_country:
Germany
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Spain
Greece
Canada
France


acronym: Sorafenib or Placebo in combination with TACE for intermediate HCC (SPACE)

lead_sponsor: Bayer

summary: This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

ReferenceCitation: Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22.

location_facility: Gangnam Severance Hospital, Yonsei University

title: A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

location_country:
Germany
Italy
Singapore
Australia
Austria
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France


acronym: CERTO

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary:
Primary objective of the study's Safety run-in:

- To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Primary objective of the study's Randomization Part:

- To assess the efficacy of cilengitide in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.

Study design and plan:

This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in part in subjects with advanced non-small cell lung cancer (NSCLC).

During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide intravenous [i.v.] 1000 milligram [mg] to 2000 mg twice a week) in a classical 3+3 subjects (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and schedule reduction rules.

In the safety run-in 12 subjects were included and evaluated for safety and feasibility of different escalating doses of cilengitide administered twice weekly in combination with cetuximab, cisplatin and vinorelbine or gemcitabine.

After completion of the safety run-in, the randomized part will be started, during which all subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be closed with implementation of Amendment No. 4 (dated 20 December 2010):

• Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the following:

Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on Days 1 and 8 of every 3-week chemotherapy cycle, or
Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on Days 1 and 8 of every 3-week chemotherapy cycle.

The decision which of the 2 chemotherapy regimens will be applied for a given subject is at the discretion of the treating investigator.

• Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as described for Group A.

Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December 2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue to be treated as planned.

• Group C: Cetuximab and platinum-based chemotherapy as described for Group A

Chemotherapy will be given until radiographically documented progressive disease (PD) or unacceptable toxicity but for no more than 6 cycles.

Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable toxicity.

Randomization will be performed centrally using an interactive voice/web response system (IXRS). A stratified block randomization procedure will be employed using chosen first-line chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification criterion.

ReferenceCitation: Vansteenkiste J, Barlesi F, Waller CF, Bennouna J, Gridelli C, Goekkurt E, Verhoeven D, Szczesna A, Feurer M, Milanowski J, Germonpre P, Lena H, Atanackovic D, Krzakowski M, Hicking C, Straub J, Picard M, Schuette W, O'Byrne K. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO). Ann Oncol. 2015 Aug;26(8):1734-40. doi: 10.1093/annonc/mdv219. Epub 2015 May 4.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Queensland University of Technology - QUT ePrints

title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Chemotherapy Alone as First Line Treatment for Subjects With Advanced NSCLC

location_country:
Ireland
Germany
Italy
Poland
Belgium
Spain
Czech Republic
France


title: Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial

acronym: STAR

summary: Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

ReferenceType: background

ReferenceCitation: Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70. doi: 10.1016/j.eururo.2005.05.015.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Belarus
Italy
Slovakia
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Belgium
Spain
Greece
Ukraine
Czech Republic
Russian Federation
France


title: FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction (UA/NSTEMI) Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography (OASIS 8)

acronym: FUTURA/OASIS 8

summary: The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

ReferenceCitation: FUTURA/OASIS-8 Trial Group; Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.

ReferenceCitation: Ducrocq G, Jolly S, Mehta SR, Rao SV, Patel T, Moreno R, Gao P, Steg PG. Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002044. doi: 10.1161/CIRCINTERVENTIONS.114.002044.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Steg PG, Mehta S, Jolly S, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Chrolavicius S, Rao SV, Granger CB, Pogue J, Laing S, Yusuf S. Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.

location_country:
France
Germany
Italy
Poland
India
Hungary
Argentina
United Kingdom
Brazil
Netherlands
United States
Korea, Republic of
Spain
Greece
Bulgaria
Canada
Russian Federation
Czech Republic


title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

summary: The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

enrollment_type: Anticipated

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Poland
Netherlands
Belgium
South Africa
Czech Republic
France

location_facility: ORL oddělení , Karlovarská krajská nemocnice a. s.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: ORL oddělení, Karlovarská krajská nemocncie a.s.

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Teaching University Hospital, ORL klinika

location_facility: University Hospital Brussels, ENT department

location_facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

location_facility: University Hospital Leuven, ENT Department

location_facility: Centre Hospitalier de Bretagne Sud Service

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie


title: A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity

summary: The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
El Salvador
Spain
France

location_facility: 1246.4.3303A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49011 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49008 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44013 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49010 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32008 Boehringer Ingelheim Investigational Site


title: A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.

summary: The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire

status: Withdrawn

location_country:
United States
Germany
France

location_facility: 1219.4.01005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3301A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01006 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3303A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01008 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3308A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01007 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3302A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49006 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

summary: The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

lead_sponsor: Biogen

location_country:
Finland
Germany
Italy
Poland
India
Israel
Argentina
Romania
Australia
Brazil
Netherlands
Sweden
United States
Czechia
Bulgaria
Canada
Russian Federation
France


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

ReferenceCitation: Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

ReferenceCitation: Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

evidence: open (via free article)

ReferenceCitation: Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

ReferenceCitation: Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

lead_sponsor: Tibotec BVBA

sponsor_collaborators:
Tibotec BVBA
Tibotec Pharmaceutical Limited

location_country:
Germany
Poland
Israel
United Kingdom
Australia
Brazil
Netherlands
Austria
Belgium
Sweden
United States
Spain
Switzerland
Canada
Puerto Rico
France


acronym: TAURUS

summary: The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

ReferenceCitation: Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.

title: A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Ireland
Poland
Australia
Czechia
Canada
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Iceland
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
South Africa
Russian Federation
Sweden


title: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures

acronym: ELEVATE

summary: The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

status: Terminated

ReferenceCitation: Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D; ELEVATE Study Group. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709.

location_country:
Italy
Poland
India
Argentina
Belgium
United States
Korea, Republic of
Spain
Pakistan
Taiwan
Canada
Russian Federation
France


lead_sponsor: Pfizer

summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

ReferenceCitation: Murphy DA, Rini BI, Escudier B, Motzer RJ, Wang P, Li S, Williams JA, Tarazi JC, Martini JF. Angiogenic and immunomodulatory biomarkers in axitinib-treated patients with advanced renal cell carcinoma. Future Oncol. 2020 Jun;16(17):1199-1210. doi: 10.2217/fon-2020-0212. Epub 2020 May 4.

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

ReferenceCitation: Bracarda S, Bamias A, Casper J, Negrier S, Sella A, Staehler M, Tarazi J, Felici A, Rosbrook B, Jardinaud-Lopez M, Escudier B. Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial. Clin Genitourin Cancer. 2019 Jun;17(3):e689-e703. doi: 10.1016/j.clgc.2019.03.017. Epub 2019 Apr 1.

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

ReferenceCitation: Escudier B, Michaelson MD, Motzer RJ, Hutson TE, Clark JI, Lim HY, Porfiri E, Zalewski P, Kannourakis G, Staehler M, Tarazi J, Rosbrook B, Cisar L, Hariharan S, Kim S, Rini BI. Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial. Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

ReferenceCitation: Ueda T, Uemura H, Tomita Y, Tsukamoto T, Kanayama H, Shinohara N, Tarazi J, Chen C, Kim S, Ozono S, Naito S, Akaza H. Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol. 2013 Jun;43(6):616-28. doi: 10.1093/jjco/hyt054. Epub 2013 Apr 28.

ReferenceCitation: Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254.

ReferenceCitation: Cella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer. 2013 Apr 30;108(8):1571-8. doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.

ReferenceCitation: Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4. Erratum In: Lancet. 2012 Nov 24;380(9856):1818.

location_facility: University Department of Medical Oncology/Oxford Cancer Centre

location_facility: Loyola University Chicago Cardinal Bernardin Cancer Center

location_facility: Universitaets-Klinik fuer Innere Medizin I

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

location_facility: Raleigh Hematology Oncology Associates, P.C.

location_facility: Sapporo Medical University School of Medicine

location_facility: Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.

location_facility: Heidelberg Repatriation Hospital, Austin Health

location_facility: Institut Catala D'Oncologia L'Hospitalet

location_facility: Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

location_facility: Klinika Urologii i Onkologii Urologicznej

location_facility: Struttura Complessa di Oncologia Medica A

location_facility: Klinikum Region Hannover Krankenhaus Siloah

location_facility: Tokyo Women's Medical University Hospital

location_facility: Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

location_facility: Cancer Research Center named after N.N. Blokhin, Biotherapy Department

location_facility: Bhagwan Mahaveer Cancer Hospital and Research Center

location_facility: Brian LeBerthon, MD, A Medical Corporation

location_facility: University of Minnesota Medical Center Fairview

location_facility: RSM Durham Regional Cancer Centre Lakeridge Health Oshawa

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hematology and Oncology Associates of SC, LLC - Eastside Medical Center

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Dept. of Medical Oncology, Tata Memorial Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano

location_facility: Russian Research Center of Roentgenology and Radiology

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: East Valley Hematology and Oncology Medical Group

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Dipartimento dei laboratori diagnositici e per le terapie cellulari

location_facility: Cancer Research Center named after N.N.Blokhin, Chemotherapy Department

location_facility: Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien

location_facility: Unita' Operativa Oncologia Medica 2, Regione del Veneto

location_facility: Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS

location_facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

location_facility: British Columbia Cancer Agency - Cancer Centre for the Southern Interior

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

location_facility: Alexandra University Hospital / Oncology Dept.

location_facility: Vanderbilt-Ingram Cancer Center-Cool Springs

location_facility: Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

location_facility: Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Raleigh Hematology Oncology Associates, DBA

location_facility: Taichung Veterans General Hospital, Department of Surgery

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Ballarat Oncology & Haematology Services

location_facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: University of Miami Sylvester at Deerfield Beach

location_facility: UOC Oncologia Medica, Ospedale San Donato

location_facility: UOC Oncologia Medica B, IRCCS AO Universitaria San Martino

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica

location_facility: Georgetown University Hospital, Lombardi Cancer Center

location_facility: UO di Oncologia ed Ematologia, Istituto Clinico Humanitas

location_facility: St. John's Mercy, David C. Pratt Cancer Center

location_facility: Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: University of Miami Hospital and Clinics

location_facility: "Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Chattanooga Oncology Hematology Associates P.C.

location_facility: Tokyo Women's Medical University Medical Center East, Department of Urology

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Moscow Research Institute of Oncology P.A. Herzen

location_facility: Agajanian Institute of Oncology and Hematology

location_facility: National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer

location_facility: The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital

location_facility: Department of Oncology, National Taiwan University Hospital

location_facility: University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology

location_facility: Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc

location_facility: Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology

location_facility: The Cancer Center at Hackensack University Medical Center - The Hillcrest Building

location_facility: Royal Marsden Hospital NHS Foundation Trust

location_facility: The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation

location_facility: Chattanooga Oncology and Hematology Associates, PC

location_facility: Lake University - Ireland Cancer Center (LUICC)

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: University of Birmingham, CRUK Institute for Cancer Studies

location_facility: Virginia Mason Medical Center, Section of Hematology/Oncology

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Department of Medical Oncology, St. Bartholomew's Hospital

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: US Oncology Research and Clinical Pharmacy

location_facility: Chattanooga Oncology & Hematology Associates

location_facility: Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Tianjin Oncology Hospital,biology treatment department

location_facility: University of Colorado Denver: Division of Medical Oncology

location_facility: Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

location_facility: Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik

location_facility: Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie

location_facility: Chang Gung Medical Foundation-Linkou Branch

title: AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Ireland
Poland
Australia
Brazil
Japan
Canada
France
Slovakia
United States
India
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


title: A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.

acronym: DRIVER

summary: The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will again evaluate, after 2 months of treatment if the subject wants to increase the dosage from 10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg or 5 mg. It will not be possible after this point to increase or decrease the dosage for the rest of the study. The subject will be asked to attend the clinic on four separate occasions over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor will ask the subject about their medical history, and the subject will be given a medical examination (including your heart rate, blood pressure and weight). The medical examination will also include an ECG. The subject will be asked to provide a blood and urine sample, which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their mood and feelings. The subject qualifies, they will have an interview with a trained mental health care provider who will assess their level of depression. At the end of the visit, the doctor will provide the subject with a diary in which they must record details about their attempts at sexual activity during the next 4 weeks. The subject will be asked to make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in different questionnaires about their sexuality, mood and feelings, general quality of life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples will be collected. An interview with the trained mental health care provider who will re-assess their level of depression. At this visit all information collected so far will be assessed and the doctor will check to see if the requirements to enter the treatment period are fulfilled. The subject may be excluded from further participation in the study, for example due to results of the blood analysis or if your level of depression did not meet the criteria for the study. If the subject is able to participate to the study they will be given the study drug. At each visit, adverse events will be discussed and whether there is any change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or Premature Termination. At every visit the subject will receive a diary in which they must record details about their attempts at sexual activity during the period between each visit and the number of tablets taken. Subjects will also be asked to fill in different questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity. Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study medication, 24 hours after the last dose of study medication. The doctor will give the study drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the subject will be required to return to the clinic for a physical examination, vital signs and have blood samples and ECG obtained. They will also be asked to fill in different questionnaires.

location_country:
Italy
United States
Spain
Canada
France


summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.

ReferenceCitation: Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.

ReferenceCitation: Ferrari A, Merks JHM, Chisholm JC, Orbach D, Brennan B, Gallego S, van Noesel MM, McHugh K, van Rijn RR, Gaze MN, Martelli H, Bergeron C, Corradini N, Minard-Colin V, Bisogno G, Geoerger B, Caron HN, De Salvo GL, Casanova M. Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy. Eur J Cancer. 2020 May;130:72-80. doi: 10.1016/j.ejca.2020.01.029. Epub 2020 Mar 13.

ReferenceCitation: Chisholm JC, Merks JHM, Casanova M, Bisogno G, Orbach D, Gentet JC, Thomassin-Defachelles AS, Chastagner P, Lowis S, Ronghe M, McHugh K, van Rijn RR, Hilton M, Bachir J, Furst-Recktenwald S, Geoerger B, Oberlin O; European paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortium. Open-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study). Eur J Cancer. 2017 Sep;83:177-184. doi: 10.1016/j.ejca.2017.06.015. Epub 2017 Aug 23.

location_facility: CHU Hopital Sud; Service d'Hematologie Pediatrique

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer

location_facility: Center for Children's Hematology, Oncology and Immunology

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie

location_facility: Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Emma Kinderziekenhuis; Dept of Pediatric Oncology

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Birmingham Childrens Hospital; Oncology Dept

location_facility: University Hospital Essen; Department of Pediatric Oncology

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: University Hospital Queens Medical Centre; Department of Paediatric Oncology

location_facility: Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica

location_facility: Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica

location_facility: St. James's University Hospital; Leeds Regional Paediatric Oncology Unit

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

location_facility: Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie

location_facility: Rambam Health Care Campus; Pediatric Hematology Oncology Department

location_facility: Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

location_facility: ITACI - Instituto de Tratamento do Cancer Infantil

location_facility: Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic

location_facility: CHU Bordeaux; Unite Onco-Hematologie Pediatrique

location_facility: Hopital Des Enfants; Service d Hemato-Oncologie

location_facility: CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy

location_facility: Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica

location_facility: Chr De Nantes; Service D'oncologie Pediatrique

title: An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Brazil
Netherlands
Belgium
Spain
Chile
Czechia
Canada
Russian Federation
France


acronym: VIEW 2

summary: This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

ReferenceType: result

ReferenceCitation: Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. Erratum In: Ophthalmology. 2013 Jan;120(1):209-10.

ReferenceCitation: Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.

ReferenceCitation: Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.

publisher_dissemination: British Medical Journal

ReferenceCitation: Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

ReferenceCitation: Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
France
Czech Republic
Colombia
Portugal
Slovakia
Hungary
Switzerland
Latvia
India
Belgium
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Israel


title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

acronym: CILAB

summary: This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

lead_sponsor: Sanofi

location_country:
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
United States
India
Belgium
Italy
Sweden
Netherlands
Mexico
Spain
South Africa
Russian Federation
Israel

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 840062

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 484004

location_facility: Sanofi-Aventis Investigational Site Number 840032

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 356003

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 840038

location_facility: Sanofi-Aventis Investigational Site Number 792002

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 840065

location_facility: Sanofi-Aventis Investigational Site Number 376001

location_facility: Sanofi-Aventis Investigational Site Number 724008

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 840019

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 356005

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 643009

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 076005

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 840052

location_facility: Sanofi-Aventis Investigational Site Number 076002

location_facility: Sanofi-Aventis Investigational Site Number 032003

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 724006

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 840021

location_facility: Sanofi-Aventis Investigational Site Number 643011

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 840018

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 840025

location_facility: Sanofi-Aventis Investigational Site Number 076006

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 840064

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 840034

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 356004

location_facility: Sanofi-Aventis Investigational Site Number 840009

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 840049

location_facility: Sanofi-Aventis Investigational Site Number 356007

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 032004

location_facility: Sanofi-Aventis Investigational Site Number 056005

location_facility: Sanofi-Aventis Investigational Site Number 724010

location_facility: Sanofi-Aventis Investigational Site Number 250012

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 484005

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 840057

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 724009

location_facility: Sanofi-Aventis Investigational Site Number 124002

location_facility: Sanofi-Aventis Investigational Site Number 792006

location_facility: Sanofi-Aventis Investigational Site Number 076001

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 250009

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 356002

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 032005

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 724011

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 380006

location_facility: Sanofi-Aventis Investigational Site Number 643010

location_facility: Sanofi-Aventis Investigational Site Number 840048

location_facility: Sanofi-Aventis Investigational Site Number 076007

location_facility: Sanofi-Aventis Investigational Site Number 076004

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 250011

location_facility: Sanofi-Aventis Investigational Site Number 484007

location_facility: Sanofi-Aventis Investigational Site Number 710007

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 840050

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 356001

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 840035

location_facility: Sanofi-Aventis Investigational Site Number 840058

location_facility: Sanofi-Aventis Investigational Site Number 840047

location_facility: Sanofi-Aventis Investigational Site Number 840068

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 528007

location_facility: Sanofi-Aventis Investigational Site Number 076003

location_facility: Sanofi-Aventis Investigational Site Number 528006

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 376002

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 840054

location_facility: Sanofi-Aventis Investigational Site Number 376005

location_facility: Sanofi-Aventis Investigational Site Number 710008

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 840016

location_facility: Sanofi-Aventis Investigational Site Number 376003

location_facility: Sanofi-Aventis Investigational Site Number 724013

location_facility: Sanofi-Aventis Investigational Site Number 840060

location_facility: Sanofi-Aventis Investigational Site Number 840004

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 840030

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 376007

location_facility: Sanofi-Aventis Investigational Site Number 710009

location_facility: Sanofi-Aventis Investigational Site Number 032002

location_facility: Sanofi-Aventis Investigational Site Number 376004

location_facility: Sanofi-Aventis Investigational Site Number 840044

location_facility: Sanofi-Aventis Investigational Site Number 840003

location_facility: Sanofi-Aventis Investigational Site Number 840045

location_facility: Sanofi-Aventis Investigational Site Number 840056

location_facility: Sanofi-Aventis Investigational Site Number 032001

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 380008

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 840046

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 724012

location_facility: Sanofi-Aventis Investigational Site Number 840007

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840031


title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry

acronym: IHMR

summary: This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

study_type: Observational

time_perspective: Prospective

lead_sponsor: Ethicon, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
China
Spain
South Africa
Canada
France

location_facility: South East Area Health Education Center (SEAHEC)

location_facility: CH Avignon - Service de Chirurgie Digestive

location_facility: Owen Drive Surgical Clinic of Fayetteville

location_facility: Washington University School of Medicine

location_facility: Centre for the Advancement of Minimally Invasive Surgery (CAMIS)

location_facility: Huadong Hospital- Affilated to Fudan University

location_facility: Laparoscopic Surgical Center of New York

location_facility: Service de Chirurgie Generale et Cancerologie Digestiv


title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

summary: The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

ReferenceCitation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.

lead_sponsor: AstraZeneca

location_country:
Portugal
Norway
United Kingdom
Denmark
Romania
Netherlands
Spain
Peru
Bulgaria
Canada
Russian Federation
France


summary: Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

ReferenceCitation: Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillie L, Khattry N, Kantarjian HM, Brummendorf TH. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014 Oct;89(10):947-53. doi: 10.1002/ajh.23788. Epub 2014 Jul 21.

ReferenceCitation: Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.

RetractionSource: Drug Metab Pharmacokinet. 2019 Apr;34(2):163

publisher_dissemination: Japanese Society for the Study of Xenobiotics

ReferenceCitation: Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.

ReferenceCitation: Cortes JE, Kim DW, Kantarjian HM, Brummendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012 Oct 1;30(28):3486-92. doi: 10.1200/JCO.2011.38.7522. Epub 2012 Sep 4.

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Erratum In: Nat Rev Cancer. 2012 Dec;12(12):886.

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_facility: Hospital Clinico Universitario de Valencia (CHUV)

location_facility: Oleksandrovska clinical hospital cardiological rehabilitation department

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Department of Haematology - Level 3, Bexley Wing

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: 3rd Floor Centre for Clinical Haematology

location_facility: The Hematology Hospital of Chinese Academy of Medical Science

location_facility: Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini

location_facility: Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini

location_facility: Perm Territory State Budgetary Healthcare Inst

location_facility: Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Department of Cardiology, Chris Hani Baragwanath Hospital

location_facility: Stanford Hospital and Clinics Investigational Drug Services

location_facility: Samara Regional Clinical Hospital M.I. Kalinin

location_facility: Clinical Haematology Unit - Department of Medicine

location_facility: Ospedale Ferrarotto - Divisione di Ematologia

location_facility: St-Petersburg Pavlov's State Medical University

location_facility: Dipartimento Di Ematologia Ospedale Santo Eugenio

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"

location_facility: Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

location_facility: Universitaetsklinikum Leipzig Zentrum fur Innere Medizin

location_facility: Centro De Hematologia E Hemoterapia Da Unicamp

location_facility: CIOSAD Centro de Investigaciones Oncologicas

location_facility: Johannesburg Hospital, Department of Medical Oncology

location_facility: III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: Kirov Research Institute of Hematology and Blood Transfusion of

location_facility: SEAROC Cancer Center, Soni Manipal Hospital

location_facility: Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp

location_facility: Hammersmith Hospital Clinical Trial Units

location_facility: Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital/Division of Hematology

location_facility: Centre d'Investigation Clinique- CIC INSERM802

location_facility: Tata Memorial Center, Tata Memorial Hospital

location_facility: Cherkaskiy oblasniy onkologichniy dispanser

location_facility: CHU de Charleroi - Hopital civil Marie Curie

location_facility: Clinical Diagnostic Laboratory of Komunalnyj Zaklad

location_facility: Department of Radiology, Chris Hani Baragwanath Hospital

location_facility: Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital

location_facility: Study Supplies: Regional Cancer Care Associates

location_facility: Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Japanese Red Cross Nagoya First Hospital

location_facility: Niigata University Medical and Dental Hospital

location_facility: Complejo Hospitalario de Toledo- Servicio de Hematologia.

location_facility: Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico

location_facility: Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"

location_facility: Ultrasaund Educational and Diagnostic Center

location_facility: Hamamatsu Medical University Hospital Faculty of Medicine

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH

location_facility: Hematology, Oncology & Transfusion Medicine Center

location_facility: Charite University Medical Center - Campus Virchow Klinikum

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia

location_facility: Advanced Centre for Treatment, Research and Education in Cancer

location_facility: Institut Klinichnoi Radiologii Naukovogo

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: Hospital Universitari Clinic de Barcelona

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: University Hospital Gent - Department of Hematology

location_facility: Division of Hematology, Department of Medicine

location_facility: Siouxland Hematology-Oncology Associates, LLP

title: A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Chile
Canada
France
Lithuania
Colombia
Hungary
Hong Kong
United States
Latvia
Ukraine
India
Belgium
China
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

summary: Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

design_allocation: Non-Randomized

ReferenceCitation: Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.

location_country:
Finland
Germany
Ireland
Poland
Hungary
United Kingdom
Denmark
Netherlands
Belgium
Latvia
Spain
France