Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy (ADI-PEG 20)
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|ClinicalTrials.gov Identifier: NCT01287585|
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : August 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||636 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Multi-Center Phase 3 Study of ADI-PEG 20 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed Prior Systemic Therapy|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: ADI-PEG 20
Arginine deiminase formulated with polyethylene glycol.
Drug: ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)
18 mg/m2, weekly, intramuscular, until disease progression or toxicity.
|Placebo Comparator: Placebo||
weekly, intramuscular, until disease progression or toxicity.
- Overall survival [ Time Frame: 18 months ]Overall survival - until death or study closure.
- Safety and tolerability - number of participants with adverse events. [ Time Frame: 18 months - at anticipated end of study. ]In addition to safety and tolerability, progression free survival, response rate using RECIST 1.1 and time to tumor progression will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287585
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|Study Director:||John S Bomalaski, M.D.||Polaris Group|