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| Sponsor: | ArQule |
|---|---|
| Information provided by: | ArQule |
| ClinicalTrials.gov Identifier: | NCT01070290 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: ARQ 197 Drug: Oxaliplatin, capecitabine or irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 2 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 |
| Estimated Enrollment: | 338 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ARQ 197
|
Drug: ARQ 197
120 mg capsule administered twice daily
|
|
Active Comparator: 2
Investigator's choice of oxaliplatin, capecitabine or irinotecan
|
Drug: Oxaliplatin, capecitabine or irinotecan
Investigator's choice or oxaliplatin, capecitabine or irinotecan
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | ArQule Inc., ArQule, Inc. |
| ClinicalTrials.gov Identifier: | NCT01070290 History of Changes |
| Other Study ID Numbers: | ARQ 197-206 |
| Study First Received: | February 16, 2010 |
| Last Updated: | February 17, 2010 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada |
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gastric carcinoma Locally Advanced or Metastatic Gastric Cancer |
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Irinotecan Capecitabine Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |