A Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen

Sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study ID
NCT01070290
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This will be a multi-center, open-label randomized phase 2 study designed to evaluate the progression free survival (PFS) of patients with advanced gastric cancer following treatment with either ARQ 197 or one of three standard regimens (investigator's choice). Patients with unresectable (locally advanced or metastatic) gastric carcinoma who have progressive neoplastic disease following treatment with a prior regimen consisting of at least two of the drugs 5-FU, cisplatin and docetaxel. The study will also evaluate other efficacy and safety parameters including overall response rate, overall survival and adverse events in the two treatment arms.

Key Dates

Status verified
Jan 2014

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    ARQ 197
  • Active Comparator: 2
    Investigator's choice of oxaliplatin, capecitabine or irinotecan

Primary Outcome Measure

Compare the progression-free survival (PFS) of ARQ 197 versus investigator's choice of second-line chemotherapy in patients with advanced gastric cancer who have failed first-line treatment.

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