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A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT01101906•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Detailed Description

Adult patients with advanced HCC previously treated with sorafenib will be randomized 2:1 to receive either single agent OSI-906 or placebo

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+19 more criteria

Exclusion Criteria

•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:
+13 more criteria

Locations (41)

University of California - Los Angeles

Los Angeles, California, United States

Tulane University Health Services Center

New Orleans, Louisiana, United States

Oregon Health & Science University

Portland, Oregon, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Seattle Cancer Care Alliance University of Washington

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cliniques Universitaires Saint-Luc

Brussells, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie

Bondy, France

Hôpital Henri Mondor

Créteil, France

Key Dates

Start Date

January 10, 2011

Primary Completion Date

November 4, 2011

Completion Date

December 28, 2011

Last Updated

November 20, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Interventions

OSI-906

DRUG

Placebo

DRUG

HAI or IV of Adebrelimab, Combined with Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

NCT06737913

Advanced Hepatocellular Carcinoma (HCC)

View study

TERMINATEDPHASE1/PHASE2

MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients

NCT04212221

Advanced Hepatocellular Carcinoma (HCC)

View study

UNKNOWNPHASE2

A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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