Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma Who Have Been Treated With One Prior Therapy (METIV-HCC)
The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy|
- Overall survival (OS) in Intent to Treat (ITT) population [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]Patients will be contacted every 12 weeks to track overall survival
- Progression free survival (PFS) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Patients will be evaluated for these endpoints every 8 weeks. Progression free survival (PFS) by central, independent radiology review
- Safety [ Time Frame: Throughout treatment and for 30 days after last dose ] [ Designated as safety issue: Yes ]Further characterize the safety of ARQ 197 in patients with unresectable HCC.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
The tivantinib dosage of 120 mg administered by mouth twice daily (BID), once in the morning and once in the evening, with food, for a total daily dose of 240 mg.
Other Name: ARQ197
|Placebo Comparator: Placebo||
The control arm will receive matching placebo tablets, once in the morning and once in the evening, with food, continuously.
Expression of c-Met in tumors correlates with aggressive hepatocellular carcinoma (HCC) features. Overexpression of the receptor in tumor samples or high level of blood HGF in subjects is related to higher recurrence rate after surgery for HCC, while high c-Met expression correlates with shorter survival in HCC subjects. In summary, c-Met holds an important prognostic role in the natural history of HCC. This Phase 3 study in MET Diagnostic-High inoperable HCC subjects has been designed based on the results from the randomized, controlled Phase 2 study conducted by ArQule, Inc. with tivantinib versus placebo in subjects with MET Diagnostic-High inoperable HCC who have failed one prior systemic therapy, mentioned above. The purpose of this study is to confirm the efficacy of tivantinib in MET Diagnostic-High HCC subjects who were previously treated with one systemic therapy, and to further evaluate the safety profile of the experimental drug in this subject population.