Gastric Cancer Clinical Trial
Official title:
A Phase Ib, Open-label Study of Safety and Pharmacokinetics of Volitinib in Combination With Docetaxel in Patients With Advanced Gastric Cancer
The purpose of this study is to evaluate the safety and tolerability of volitinib in combination with docetaxel in patients with locally advanced or metastatic gastric cancer and to determine the Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of volitinib in combination with docetaxel.
This is a phase Ib, open-label study.
There are two stages to this study: a dose-escalation stage and a dose-expansion stage.
Approximately 40-50 patients will be enrolled in this two-stage study, about 12-18 patients
in the dose-escalation stage and approximately 30 patients in the dose-expansion stage.
Dose escalation stage
Gastric cancer patients who failed the first line therapy (no matter the cMet status) who
meet the eligibility criteria will be enrolled into this stage.
Cohort 1: Volitinib 600mg QD + docetaxel 75mg/m2 Cohort 2: Volitinib 800mg QD+ docetaxel
75mg/m2 The conventional 3+3 design (3 patients per dose cohort, with the potential to add
additional 3 patients to the same cohort to further evaluate toxicity) will be applied for
dose escalation and MTD or RP2D determination. Each treatment cycle will be composed of 3
weeks or 21 days. Dose escalation and entry of the next cohort will occur only after
acceptable tolerance has been demonstrated throughout the entire Cycle1.
Dose expansion Stage
Additional patients will be enrolled at the MTD or RP2D to further refine the safety,
tolerability, PK, and efficacy at this dose. Patients will be limited to the metastatic /
locally advanced gastric cancer patients who failed the first therapy and with positive cMet
test results. Patients will be divided into two treatment groups according their c-Met test
results:
Group A: FISH + , IHC -/+(about 15 patients) Group B: IHC+ and FISH- (about 15 patients)
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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