ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors (NCT01055067) | Clinical Trial Compass
TerminatedPhase 2
ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors
Stopped: The study was terminated early for futility according to the stopping rule of the Simon 2-stage design.
United States27 participantsStarted 2010-02-02
Plain-language summary
This is a multicenter, single-arm study for safety and efficacy.
Who can participate
Age range16 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically-confirmed non-central nervous system germ cell tumor (non-CNS GCT), both seminomas and nonseminomas are allowed.
✓. Male subjects 16 years of age or older.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 1.
✓. Documented progression during or following equal to or greater than 1 prior platinum-containing chemotherapy regimen(s) (no limit to number of lines of prior treatment), and considered platinum-resistant by the Investigator. Subjects who have progressed or whose tumors have recurred after stem cell transplantation are also allowed.
✓. All subjects must have either declined or not be a candidate for curative therapy. In general, this means a subject would have to have progressive disease (PD) after receiving high-dose chemotherapy, have certain features making them ineligible for high-dose chemotherapy, or have refused high-dose chemotherapy despite being informed of its curative potential.
✓. Subjects must have radiographically measurable disease as defined by RECIST 1.1 and meet one of the following criteria:
✓. Subjects should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or chronic co-morbidity that would interfere with therapy.
✓. Subjects must agree to use double-barrier contraceptive measures or avoidance of intercourse during the study and for 90 days after the last dose of study drug.
Exclusion criteria
✕
What they're measuring
1
Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors
Timeframe: Baseline up to first objective response, up to 1 year 9 months postdose
. Previous or concurrent cancer that is distinct from GCT in primary site or histology, EXCEPT treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated equal to or greater than 3 years prior to enrollment is permitted.
✕. History of cardiac disease:
✕. Active clinically serious infection(s) defined as equal to or greater than Grade 2 according to NCI CTCAE, version 4.0.
✕. Known metastatic brain or meningeal tumors, unless the subject is greater than 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study drug and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study drug.
✕. Any primary CNS GCT.
✕. Concurrent treatment with anticancer therapies including cytotoxic chemotherapy, immunotherapy, radiotherapy, vaccines or investigational therapy during the study or within 3 weeks of first dose of study drug.
✕. Any major surgical procedure within 3 weeks prior to first dose of study drug.
✕. Prior therapy with c-MET inhibitors, including ARQ197.