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A Randomized, Placebo-controlled, Double-blind Phase 2 Study with OSI-906 in Patients with Advanced HCC

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01101906

Astellas Study ID

The unique identification code given by the study sponsor.

OSI-906-206

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2010-018739-17

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Condition

Liver Cancer

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jan 2011 - Dec 2011

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

23

A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment with OSI-906 in Patients with Advanced Hepatocellular Carcinoma (HCC) after Failure of First-line Treatment with Sorafenib

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare

Napoli, Italy, 80131

Hôpital Henri Mondor

Creteil cedex, France, 94010

Oregon Health & Science University

Portland, United States, 97239

Ospedale Fatebenefratelli, Dipartimento Medicina Interna

Napoli, Italy, 80123

Johns Hopkins Singapore International Medical Centre

Singapore, Singapore, 308433

Pusan National University Hospital

Busan, Republic of Korea, 602-739

Hospital Puerta de Hierro Majadahonda

Madrid, Spain, 28220

Hôpital Saint-Antoine

Paris cedex 12, France, 75012

Universitatsklinikum des Saarlandes

Homburg, Germany, 66421

Changhua Christian Hospital

Changhua, Taiwan, Province of China, 500

Singapore General Hospital

Singapore, Singapore, 169608

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, Germany, 39120

Seoul National University Hospital

Seoul, Republic of Korea, 110-774

Severance Hospital

Seoul, Republic of Korea, 120-752

Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I

Milano, Italy, 20122

Hopital Jean Verdier – Dervice d’Hepato-Gastroenterologie

Bondy Cedex, France, 93143

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, Province of China, 807

Cliniques Universitaires Saint-Luc

Brussells, Belgium, 1200

Medical College of Wisconsin

Milwaukee, United States, 52336

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Tulane University Health Services Center

New Orleans, United States, 70112

China Medical University Hospital

Taichung, Taiwan, Province of China

Samsung Medical Center

Seoul, Republic of Korea, 135-710

Hospital Clinic Provincial

Barcelona, Spain, 08036

Sutter Pacific Medical Foundation

San Francisco, United States, 94115

Hôpital de Tenon

Paris cedex 12, France, 75020

Taichung Veterans General Hospital

Taichung, Taiwan, Province of China, 40705

Clinica Universitaria de Navarra

Pamplona, Spain, 31008

Kyungpook National University Hospital

Daegu, Republic of Korea, 700-721

Hopital de la Timone

Marseille Cedex 5, France, 13385

Hopital l'Archet 2

Nice cedex 03, France, 6202

Universitatsklinikum Essen

Essen, Germany, 45122

National Cancer Center

Goyang-si, Republic of Korea, 410-769

Virginia Mason Medical Center

Seattle, United States, 98101

Universitätsklinikum Halle

Halle, Germany, 06097

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia

Palermo, Italy, 90127

University of California – Los Angeles

Los Angeles, United States, 90095

Seattle Cancer Care Alliance University of Washington

Seattle, United States, 98109

Chang Gung Medical Foundation LinKou Branch

TaoYuan, Taiwan, Province of China, 333

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Centre Rene Gauducheau

Saint Herblain cedex, France, 44805

Queen Mary Hospital

Hong Kong, Hong Kong

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