Study Stopped
Company decided not to pursue the development of this drug in this patient population at this time
A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC
2 other identifiers
interventional
23
10 countries
41
Brief Summary
This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedStudy Start
First participant enrolled
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2011
CompletedNovember 20, 2024
November 1, 2024
10 months
April 8, 2010
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression (TTP)
Time from randomization to radiological disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
20 months
Secondary Outcomes (10)
Overall Survival (OS)
23 months
Progression Free Survival (PFS)
23 months
Time to Progression (including clinical progression) (TTPc)
23 months
Disease Control Rate (DCR)
23 months
Overall Response Rate
23 months
- +5 more secondary outcomes
Study Arms (2)
Arm A: OSI-906
EXPERIMENTAL150 mg BID
Arm B: Placebo
PLACEBO COMPARATORPlacebo BID
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of advanced HCC. Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients is acceptable. For patients without cirrhosis histological confirmation is mandatory
- Patients must have received prior systemic treatment for advanced HCC with sorafenib and had confirmed disease progression or had discontinued sorafenib due to a drug related toxicity
- Patient has received their last dose of sorafenib at least 14 days prior to randomization
- Patient has recovered from sorafenib or investigational agent related toxicity to ≤ grade 2
- Measurable disease according to RECIST (version 1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 1
- Child-Pugh Status A or B(7)
- Barcelona Clinic Liver Cancer (BCLC) stage B/C
- Previous local therapy (eg, surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) is permitted if ≥ 21 days before randomization
- Fasting glucose ≤ 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for ≥ 4 weeks at the time of randomization
- Following laboratory parameters (determined by laboratory):
- Platelets ≥ 60 x 10\^9/L
- Hemoglobin ≥ 8.5 g/dL
- Absolute neutraphil count (ANC) ≥ 1.5 x 10\^9/L
- Potassium within normal limits (supplementation may be used)
- +14 more criteria
You may not qualify if:
- Child-Pugh B (8 - 9) or C
- Patients who are candidates for potentially curative intervention (ie, surgical resection or transplantation)
- Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
- Prior insulin-like growth factor - 1 receptor (IGF-1R) therapy
- Patients requiring interferon
- Patients with uncontrolled symptomatic ascites
- Prior investigational agent within 21 days prior to randomization
- History of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (eg, Crohn's disease, ulcerative colitis, etc)
- History of organ allograft including liver transplant
- Malignancy other than HCC within the past 3 years:
- Exceptions: resected basal cell or squamous cell carcinoma of the skin, cured in situ cervical carcinoma, cured ductal carcinoma in situ of the breast, and/or cured superficial bladder cancer
- History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
- History of arrhythmia (multifocal premature ventricular contractions \[PVCs\], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded
- QTcF interval at screening ≥ 450 msec
- Use of drugs that have a known risk of causing Torsades de Pointes (TdP) ('Torsades List' on www.azcert.org/medical-pros/drug-lists/by category.cfm)are prohibited within 14 days prior to randomization
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of California - Los Angeles
Los Angeles, California, 90095, United States
Tulane University Health Services Center
New Orleans, Louisiana, 70112, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance University of Washington
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 52336, United States
Cliniques Universitaires Saint-Luc
Brussells, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie
Bondy, 93143, France
Hôpital Henri Mondor
Créteil, 94010, France
Hopital de la Timone
Marseille, 13385, France
Hopital l'Archet 2
Nice, 6202, France
Hôpital Saint-Antoine
Paris, 75012, France
Hôpital de Tenon
Paris, 75020, France
Centre Rene Gauducheau
Saint-Herblain, 44805, France
Universitatsklinikum Essen
Essen, 45122, Germany
Universitätsklinikum Halle
Halle, 06097, Germany
Universitatsklinikum des Saarlandes
Homburg, 66421, Germany
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, 39120, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I
Milan, 20122, Italy
Ospedale Fatebenefratelli, Dipartimento Medicina Interna
Napoli, 80123, Italy
IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare
Napoli, 80131, Italy
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia
Palermo, 90127, Italy
Singapore General Hospital
Singapore, 169608, Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 602-739, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
National Cancer Center
Goyang-si, 410-769, South Korea
Seoul National University Hospital
Seoul, 110-774, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Coruna, 15706, Spain
Hospital Clinic Provincial
Barcelona, 08036, Spain
Hospital Puerta de Hierro Majadahonda
Madrid, 28220, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chang Gung Medical Foundation LinKou Branch
Taoyuan District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 12, 2010
Study Start
January 10, 2011
Primary Completion
November 4, 2011
Study Completion
December 28, 2011
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.