Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

NCT ID: NCT00849667

Last Updated: 2022-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-16

Study Completion Date

2013-04-12

Brief Summary

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This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Detailed Description

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Conditions

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Ovarian Cancer

Keywords

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ovarian cancer relapsed ovarian cancer Platinum-sensitive Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Farletuzumab (1.25 mg/kg)

Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.

Group Type ACTIVE_COMPARATOR

Farletuzumab

Intervention Type DRUG

Farletuzumab IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin IV infusion.

Taxane

Intervention Type DRUG

Taxane (Paclitaxel or Docetaxel) IV infusion.

Farletuzumab (2.5 mg/kg)

Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.

Group Type ACTIVE_COMPARATOR

Farletuzumab

Intervention Type DRUG

Farletuzumab IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin IV infusion.

Taxane

Intervention Type DRUG

Taxane (Paclitaxel or Docetaxel) IV infusion.

Placebo

Participants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.

Group Type PLACEBO_COMPARATOR

Carboplatin

Intervention Type DRUG

Carboplatin IV infusion.

Taxane

Intervention Type DRUG

Taxane (Paclitaxel or Docetaxel) IV infusion.

Farletuzumab-matched placebo

Intervention Type DRUG

Farletuzumab-matched placebo IV infusion.

Interventions

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Farletuzumab

Farletuzumab IV infusion.

Intervention Type DRUG

Carboplatin

Carboplatin IV infusion.

Intervention Type DRUG

Taxane

Taxane (Paclitaxel or Docetaxel) IV infusion.

Intervention Type DRUG

Farletuzumab-matched placebo

Farletuzumab-matched placebo IV infusion.

Intervention Type DRUG

Other Intervention Names

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MORAb-003

Eligibility Criteria

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Inclusion Criteria

* A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
* Must have measurable disease by CT or MRI scan
* Must have relapsed radiologically with a randomization date within ≥6 and \< 24 months of completion of first-line platinum chemotherapy
* Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
* Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
* Must be a candidate for carboplatin and taxane therapy
* Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria

* Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs \<6 months or \>24 months from the last platinum therapy
* Subjects who have received other therapy to treat their ovarian cancer since relapse
* Known central nervous system (CNS) tumor involvement
* Evidence of other active invasive malignancy requiring treatment in the past 5 years
* Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
* Previous treatment with MORAb-003 (farletuzumab)
* Clinical contraindications to use of a taxane
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eisai Europe Ltd. (United Kingdom)

INDUSTRY

Sponsor Role collaborator

Morphotek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Oncology Specialties, PC

Huntsville, Alabama, United States

Site Status

Arizona Hematology & Oncology Associates

Phoenix, Arizona, United States

Site Status

St. Joseph's Hospital, Barrow Neurology Clinics

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates

Tucson, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Providence St. Joseph Medical Center

Burbank, California, United States

Site Status

California Cancer Care, Inc.

Greenbrae, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

University of California Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Gynecologic Oncology Associates

Newport Beach, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Catholic Health Initiatives

Colorado Springs, Colorado, United States

Site Status

Denver Health and Hospital Authority

Denver, Colorado, United States

Site Status

Hematology Oncology P.C.

Stamford, Connecticut, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Palm Beach Institute of Hematology and Oncology

Boynton Beach, Florida, United States

Site Status

University Cancer Institute

Boynton Beach, Florida, United States

Site Status

Gainsville Hematology Oncology Associates

Gainesville, Florida, United States

Site Status

Baptist Cancer Institute

Jacksonville, Florida, United States

Site Status

Jupiter Medical center Physician's Group

Jupiter, Florida, United States

Site Status

Hematology/Oncology Associates

Lake Worth, Florida, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Sarasota Memorial Healthcare System

Sarasota, Florida, United States

Site Status

Gulfcoast Oncology

St. Petersburg, Florida, United States

Site Status

Oncology-Hematology Associates of W. Broward P.A.

Tamarac, Florida, United States

Site Status

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Kaiser Permanente - Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Loyola University Chicago

Maywood, Illinois, United States

Site Status

Midwest Cancer Research Group

Skokie, Illinois, United States

Site Status

Central DuPage Hospital

Winfield, Illinois, United States

Site Status

St. Francis Hospital & Health Centers

Indianapolis, Indiana, United States

Site Status

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Norton Healthcare

Louisville, Kentucky, United States

Site Status

Hematology & Oncology Specialists

Metairie, Louisiana, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

John Hopkins University

Baltimore, Maryland, United States

Site Status

Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Frederick Memorial Hospital

Frederick, Maryland, United States

Site Status

Barbara Ann Kamanos Cancer Center

Detroit, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Saint Mary's Health Care

Grand Rapids, Michigan, United States

Site Status

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

Park Nicollet Institute

Saint Louis Park, Minnesota, United States

Site Status

Saint Francis Memorial Health Center

Grand Island, Nebraska, United States

Site Status

Good Samaritan Hospital Cancer Center

Kearney, Nebraska, United States

Site Status

The Center for Cancer and Hematologic Disease

Camden, New Jersey, United States

Site Status

Hematology-Oncolgy Associates of NNJ-PA

Denville, New Jersey, United States

Site Status

John Theurer Cancer Center at Hackensack University MC

Hackensack, New Jersey, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Cooper Cancer Institute

Voorhees Township, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Arena Oncology Associates

Lake Success, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Piedmont Hematology & Oncology

Winston-Salem, North Carolina, United States

Site Status

Catholic Health Initiatives

Cincinnati, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Providence Oncology & Hematology Care

Portland, Oregon, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Willamette Valley Cancer Center

Springfield, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Site Status

Oncology Hematology Associates

DuBois, Pennsylvania, United States

Site Status

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Oncology, PA

Austin, Texas, United States

Site Status

Texas Oncology, P.A.

Bedford, Texas, United States

Site Status

Texas Oncology, PA

Dallas, Texas, United States

Site Status

Baylor Sammons Cancer Center

Dallas, Texas, United States

Site Status

International Beneficence Clinical Research, L.L.C.

Harlingen, Texas, United States

Site Status

University of Texas Health Science Center at Houston Medical School

Houston, Texas, United States

Site Status

South Texas Oncology and Hematology, PA

San Antonio, Texas, United States

Site Status

Scott and White Memorial Hospital

Temple, Texas, United States

Site Status

US Oncology Research

Wichita Falls, Texas, United States

Site Status

Northern Utah Associates

Ogden, Utah, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, United States

Site Status

Peninsula Cancer Institute - Riverside Gynecology Oncology

Newport News, Virginia, United States

Site Status

Harrison Bremerton Hematology and Oncology

Bremerton, Washington, United States

Site Status

Providence Everett Medical Center

Everett, Washington, United States

Site Status

Cancer Care Northwest-South

Spokane, Washington, United States

Site Status

Northwest Cancer Specialists, PC

Vancouver, Washington, United States

Site Status

Aurora Health Care

West Allis, Wisconsin, United States

Site Status

Hospital Zonal Especializado en Oncología de Lanús

Buenos Aires, , Argentina

Site Status

Consultorios Medicos Privados SA

Buenos Aries, , Argentina

Site Status

Fundación Sanatorio Güemes

CABA, , Argentina

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Clinica Universitaria Reina Fabiola

Códoba, , Argentina

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Instituto Medico Platense

La Plata, , Argentina

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Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

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Hospital Bocalandro

Loma Hermosa, , Argentina

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Centro Oncologico Integral

Mar del Plata, , Argentina

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CER Instituto Medico

Quilmes, , Argentina

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Centro Médico San Roque

San Miguel de Tucumán, , Argentina

Site Status

Centro Medico de Alta Complejidad Cemac

San Salvador de Jujuy, , Argentina

Site Status

ISIS Centro Especializado de LUCE SA

Santa Fe, , Argentina

Site Status

Tweed Hospital

Tweed Heads, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

The Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Site Status

Mater Adult Hospital

South Brisbane, Queensland, Australia

Site Status

North Adelaide Oncology Clinical Trials

North Adelaide, South Australia, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Kaiser-Franz-Josef Spital

Vienna, , Austria

Site Status

Krankenhaus Wien-Hietzing

Vienna, , Austria

Site Status

Landeskrankenhaus Villach

Villach, , Austria

Site Status

Institut Jules Bordet

Brussels, , Belgium

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

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UZ Gent

Ghent, , Belgium

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AZ Groeninge - Campus Maria's Voorzienigheid

Kortrijk, , Belgium

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UZ Leuven

Leuven, , Belgium

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CHU de Liège

Liège, , Belgium

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Sint-Augustinuskliniek

Wilrijk, , Belgium

Site Status

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, , Brazil

Site Status

Instituto de Pesquisas Clínicas para Estudos Multicêntricos

Caxias do Sul, , Brazil

Site Status

Santa Casa da Misericórdia de Curitiba

Curitiba, , Brazil

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Instituto do Câncer do Ceará - ICC

Fortaleza, , Brazil

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Hosp. Araujo Jorge

Goiânia, , Brazil

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Associação Hospital de Caridade Ijuí

Ijuí, , Brazil

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Clinica de Neoplasias Litoral

Itajaí, , Brazil

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Hospital Amaral Carvalho

Jaú, , Brazil

Site Status

Liga Norte-Riograndense Contra o Câncer

Natal, , Brazil

Site Status

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status

Clínica de Oncologia de Porto Alegre S/S Ltda

Porto Alegre, , Brazil

Site Status

Instituto Ribeirãopretano de Combate ao Câncer

Ribeirão Preto, , Brazil

Site Status

Clínica Oncologistas Associados

Rio de Janeiro, , Brazil

Site Status

INCA - Instituto Nacional do Câncer

Rio de Janeiro - RJ, , Brazil

Site Status

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

Salvador, , Brazil

Site Status

Clínica AMO - Assistência Multidiciplinar em Oncologia

Salvador, , Brazil

Site Status

Centro de Estudos de Oncologia da FMABC

Santo André, , Brazil

Site Status

Saúde ABC Serviços Médicos Hospitalares Ltda

Santo André, , Brazil

Site Status

Instituto do Câncer Arnaldo Vieira de Carvalho

São Paulo, , Brazil

Site Status

Certo Oncologia

São Paulo, , Brazil

Site Status

Hospital Premier

São Paulo, , Brazil

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cancer Center For The Southern Interior

Kelowna, British Columbia, Canada

Site Status

British Columbia Cancer Agency

Surrey, British Columbia, Canada

Site Status

BCCA

Vancouver, British Columbia, Canada

Site Status

The Moncton Hospital

Moncton, New Brunswick, Canada

Site Status

Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Instituto de Terapias Oncologicas

Santiago, , Chile

Site Status

Instituto Clínico Oncológico del Sur

Temuco, , Chile

Site Status

Instituto Oncologico Ltda.

Viña del Mar, , Chile

Site Status

Centre Régional de lutte contre le cancer Paul Papin

Angers, , France

Site Status

Centre Hospitalier Louis Pasteur

Le Coudray, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

Hôpital Saint Louis

Paris, , France

Site Status

Institut Jean Godinot - Centre de lutte contre le cancer

Reims, , France

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Helios Klinikum Berlin-Buch

Buch, , Germany

Site Status

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status

Marien-Hospital Akademisches Lehrkrankenhaus

Düsseldorf, , Germany

Site Status

Frauenarztpraxis Dr. med. Gröll de Rivera

Ebersberg, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Krankenhaus Nordwest

Frankfurt, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Kath. Marienkrankenhaus gGmbH

Hamburg, , Germany

Site Status

Universität Heidelberg

Heidelberg, , Germany

Site Status

St. Vincentius Kliniken Karlsruhe

Karlsruhe, , Germany

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Universitätsklinik Magdeburg

Magdeburg, , Germany

Site Status

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Klinikum der Universität München - Innenstadt

München, , Germany

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Rotkreuzklinikum München

München, , Germany

Site Status

Klinikum Südstadt Rostock

Rostock, , Germany

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Klinikum Traunstein

Traunstein, , Germany

Site Status

University General Hospital of Heraklion

Heraklion, Crete, Greece

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Alexandra Hospital

Athens, , Greece

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General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

Athens, , Greece

Site Status

University General Hospital of Patras

Pátrai, , Greece

Site Status

Papageorgiou General Hospital

Thessaloniki, , Greece

Site Status

Queen Mary Hospital

Pokfulam, Islands District, Hong Kong

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Tuen Mun Hospital

Tuenmen, , Hong Kong

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Semmelweis Egyetem

Budapest, , Hungary

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Semmelweis Egyetem

Budapest, , Hungary

Site Status

Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

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Bács-Kiskun Megyei Önkormányzat Kórháza

Kecskemét, , Hungary

Site Status

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, , Hungary

Site Status

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet

Szolnok, , Hungary

Site Status

Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

Veszprém, , Hungary

Site Status

Apollo Hospitals International Limited

Gandhinagar, Gujarat, India

Site Status

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

Site Status

Jawaharlal Nehru Cancer Hospital & Research Centre

Bhopal, Madhya Pradesh, India

Site Status

Jehangir, Clinical Development Centre

Pune, Maharashtra, India

Site Status

Ruby Hall Clinic

Pune, Maharashtra, India

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Dr. Kamakshi Memorial Hospital

Chennai, Tamil Nadu, India

Site Status

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

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M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board

Bangalore, , India

Site Status

MNJ Institute of Oncology and Regional Cancer Centre

Hyderabaad, , India

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SK Soni Hospital

Jaipur, , India

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Bhagwan Mahaveer Cancer Hospital and Research Centre

Jaipur, , India

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Amrita Institute of Medical Sciences and Research Centre

Kochi, , India

Site Status

Lakeshore Hospital

Kochi, , India

Site Status

Tata Memorial Hospital

Mumbai, , India

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Curie Manavata Cancer Centre

Nashik, , India

Site Status

Shatabdi Superspeciality Hospital

Nashik, , India

Site Status

All India Institute of Medical Sciences

New Delhi, , India

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Regional Cancer Centre

Trivandrum, , India

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Rambam Medical Center

Haifa, , Israel

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Linn Medical Center, Clalit Health Services

Haifa, , Israel

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Wolfson Centre

Holon, , Israel

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Hadassah University Hospital Ein Kerem

Jerusalem, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

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Assaf Harofe Medical Center

Ẕerifin, , Israel

Site Status

Centro di Riferimento Oncologico

Aviano, Pordenone, Italy

Site Status

Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Istituto Ospedaliero Fondazione Poliambulanza

Brescia, , Italy

Site Status

Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche

Campobasso, , Italy

Site Status

Azienda Ospedaliera Cannizzaro

Catania, , Italy

Site Status

Humanitas Centro Catanese di Oncologia

Catania, , Italy

Site Status

Azienda Ospedaliera Sant'Anna

Como, , Italy

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Ospedale di Faenza

Faenza, , Italy

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Azienda Ospedaliera Universitaria San Martino

Genova, , Italy

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Presidio Ospedaliero Vito Fazzi

Lecce, , Italy

Site Status

Ospedale Mater Salutis ULSS 21 della regione Veneto

Legnago, , Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

Meldola, , Italy

Site Status

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Fondazione Centro San Raffaele del Monte Tabor

Milan, , Italy

Site Status

Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Azienda Ospedaliera Niguarda Cà Granda

Milan, , Italy

Site Status

Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"

Napoli, , Italy

Site Status

Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Site Status

Istituto Oncologico Veneto

Padua, , Italy

Site Status

Ospedale Santa Maria della Misericordia di Perugia

Perugia, , Italy

Site Status

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Site Status

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Azienda Policlinico Umberto I

Roma, , Italy

Site Status

Policlinico Universitario "A. Gemelli"

Roma, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Udine

Udine, , Italy

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Akashi, , Japan

Site Status

Amagasaki, , Japan

Site Status

Chiba, , Japan

Site Status

Fukuoka, , Japan

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Hidaka, , Japan

Site Status

Hiroshima, , Japan

Site Status

Kagoshima, , Japan

Site Status

Kashiwa, , Japan

Site Status

Kawasaki, , Japan

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Kōtoku, , Japan

Site Status

Kumamoto, , Japan

Site Status

Kure, , Japan

Site Status

Kurume, , Japan

Site Status

Matsuyama, , Japan

Site Status

Minatoku, , Japan

Site Status

Morioka, , Japan

Site Status

Nagoya, , Japan

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Nakano, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Sapporo, , Japan

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Sayama, , Japan

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Sendai, , Japan

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Shinjuku-Ku, , Japan

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Sunto-Gun, , Japan

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Tsu, , Japan

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Tsukuba, , Japan

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Yamagata, , Japan

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Yonago, , Japan

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Union Medica Quirurgica de Colima

Colima, , Mexico

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Triva Investigaciones Medicas Sociedad Anónima de Capital Variable

Morelia, , Mexico

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Hospital Regional de Veracruz

Veracruz, , Mexico

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VU Medisch Centrum

Amsterdam, , Netherlands

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Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

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Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

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Orbis Medisch Centrum

Sittard-Geleen, , Netherlands

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Perpetual Succour Hospital

Cebu City, Cebu, Philippines

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Cebu Gynecologic Cancer Care Clinic

Cebu, , Philippines

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Manila Doctors Hospital

Manila, , Philippines

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San Juan de Dios Hospital

Pasay, , Philippines

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St. Luke's Medical Center

Quezon City, , Philippines

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National Kidney and Transplant Institute

Quezon City, , Philippines

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Bialostockie Centrum Onkologii

Bialystok, , Poland

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Wojewodzkie Centrum Onkologii

Gdansk, , Poland

Site Status

Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach

Gliwice, , Poland

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Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, , Poland

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Centrum Onkologii Ziemi Lubelskiej

Lublin, , Poland

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Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

Olsztyn, , Poland

Site Status

Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.

Olsztyn, , Poland

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Wielkopolskie Centrum Onkologii

Poznan, , Poland

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Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

Poznan, , Poland

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SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

Rybnik, , Poland

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Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie

Szczecin, , Poland

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Wojskowy Instytut Medyczny

Warsaw, , Poland

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Hospitais da Universidade de Coimbra

Coimbra, , Portugal

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Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE

Coimbra, , Portugal

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Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)

Lisbon, , Portugal

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Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

Porto, , Portugal

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Hospital de São João

Porto, , Portugal

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Kursk Regional Oncology Centre

Kursk, , Russia

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Russian Oncology Research Center named after N.N. Blokhin

Moscow, , Russia

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Russian Oncology Research Center

Moscow, , Russia

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Moscow Research Oncology Institute n.a. P.A.Gertsen

Moscow, , Russia

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Medical Radiology Research Center of RAMS

Obninsk, , Russia

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Ryazan Regional Clinical Oncology Dispensary

Ryazan, , Russia

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City Clinical Oncology Dispensary

Saint Petersburg, , Russia

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Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare

Ufa, , Russia

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National University Hospital

Singapore, , Singapore

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National Cancer Centre

Singapore, , Singapore

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KK Women's and Children's Hospital

Singapore, , Singapore

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National Cancer Center

Gyeonggi-do, , South Korea

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Gachon University Gil Medical Center

Incheon, , South Korea

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Cheil General Hospital & Women's Healthcare Center

Seoul, , South Korea

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Seoul national univercity hospital

Seoul, , South Korea

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Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

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Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

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Hospital Virgen del Rocio

Seville, Andalusia, Spain

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Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

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Hospital Universitario Vall D'Hebron

Barcelona, Catalonia, Spain

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Hospital Clinic i Provincial

Barcelona, Catalonia, Spain

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Hospital de Mataró

Mataró, Catalonia, Spain

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Corporació Sanitaria Parc Taulí

Sabadell, Catalonia, Spain

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Hospital Mutua de Terrassa

Terrassa, Catalonia, Spain

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Fundacion Hospital Alcorcon

Alcorcón, Madrid, Communidad de, Spain

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Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Communidad de, Spain

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Hospital Universitario Ramón y Cajal

Madrid, Madrid, Communidad de, Spain

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Hospital 12 de Octubre

Madrid, Madrid, Communidad de, Spain

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Hospital General Universitario de Elche

Elche, Valencia, Spain

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Fundación Instituto Valenciano de Oncología

Valencia, Valencia, Spain

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Hospital Clinico San Carlos

Madrid, , Spain

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Universität Zürich

Zurich, , Switzerland

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National Cheng Kung University Hosptial

Tainan City, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Mackay Memorial Hospital

Taipei, , Taiwan

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Taipei Veterans General Hospital

Taipei, , Taiwan

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Tri-Service General Hospital

Taipei, , Taiwan

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

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Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"

Cherkasy, , Ukraine

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Chernivtsi Regional Clinical Oncology Dispansery

Chernivtsi, , Ukraine

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Kiev City Oncology Hospital

Kyiv, , Ukraine

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Volyn Regional Oncology Dispensary

Lutsk, , Ukraine

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Belfast City Hospital

Belfast, , United Kingdom

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Velindre Hospital

Cardiff, , United Kingdom

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University Hospital Coventry

Coventry, , United Kingdom

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Ninewells Hospital

Dundee, , United Kingdom

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Beatson Oncology Centre

Glasgow, , United Kingdom

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Leicester Royal Infirmary

Leicester, , United Kingdom

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Royal Marsden Hospital

London, , United Kingdom

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Hammersmith Hospital

London, , United Kingdom

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Clatterbridge Centre For Oncology

Metropolitan Borough of Wirral, , United Kingdom

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Derriford Hospital

Plymouth, , United Kingdom

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Poole Hospital NHS Trust

Poole, , United Kingdom

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Weston Park Hospital

Sheffield, , United Kingdom

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New Cross Hospital

Wolverhampton, , United Kingdom

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Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Brazil Canada Chile France Germany Greece Hong Kong Hungary India Israel Italy Japan Mexico Netherlands Philippines Poland Portugal Russia Singapore South Korea Spain Switzerland Taiwan Ukraine United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-005872-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MORAb003-004

Identifier Type: -

Identifier Source: org_study_id