This is a multicenter, single-arm study for safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Capsule, 120 mg, BID (360 mg), approximately 112 days
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
St Louis, Missouri, United States
Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors
The best overall response was the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. Objective response was defined as the number of participants with confirmed CR and confirmed PR after 4 cycles of therapy with ARQ 197. According to Response Evaluation Criteria in Solid Tumors v 1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: Baseline up to first objective response, up to 1 year 9 months postdose
Progression-Free Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors
Progression-free survival (PFS) is defined as the time from the date of the start of study treatment to the earlier of the dates of the first documentation of progressive disease (PD) or death due to any cause. According to Response Evaluation Criteria in Solid Tumors v 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: Baseline up to progressive disease or death (whichever occurs first), up to 1 year 9 months postdose
Overall Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors
Overall survival (OS) was defined as the time from the date of the start of study treatment to the date of death due to any cause.
Time frame: Baseline up to death (any cause), up to 1 year 9 months postdose
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Unnamed facility
New York, New York, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Lyon, France
Unnamed facility
Villejuif, France
Unnamed facility
Leeds, United Kingdom
Unnamed facility
London, United Kingdom
Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors
Treatment-emergent adverse events (TEAEs) were defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
Time frame: Baseline up to 30 days after last dose, up to 1 year 9 months postdose