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
|ClinicalTrials.gov Identifier: NCT01070290|
Recruitment Status : Withdrawn
First Posted : February 18, 2010
Last Update Posted : January 7, 2014
|First Submitted Date ICMJE||February 16, 2010|
|First Posted Date ICMJE||February 18, 2010|
|Last Update Posted Date||January 7, 2014|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01070290 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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|
|Official Title ICMJE||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|
|Brief Summary||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.|
This will be a multi-center, open-label randomized phase 2 study designed to evaluate the PFS of ARQ 197 versus investigator's choice of second-line chemotherapy in 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. Patients will be randomized to ARQ 197 arm or investigator's choice arm in a 1:1 ratio. The study will also evaluate other efficacy and safety parameters including ORR, OS and adverse events in the two treatment arms.
Patients assigned to the investigator's choice arm may receive any one of the following:
Patients randomly assigned to the ARQ arm will receive 120 mg of ARQ 197 twice daily (240 mg/day) throughout the treatment period. The treatment of ARQ 197 can be continued until unacceptable toxicity, documented progression of disease, or another discontinuation criterion is met. A cycle of ARQ 197 treatment will be defined as 21 days and cycles may be repeated every 3 weeks (21 days) based on toxicity and response.
The assigned treatment should continue until unacceptable toxicity, disease progression (clinical or radiological) or another discontinuation criterion is met.
Tumor evaluations: Tumor evaluations will be performed at 6-week or 8-week intervals. Tumor response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).
Progression-free survival: The time of disease progression-free will be calculated from date of randomization until disease progression per RECIST or death due to any cause. Patients who are alive and progression free will be censored at the date of their last tumor evaluation.
Overall response rate: The ORR will be calculated for the intent to treat patient population as the number of patients with a confirmed complete response or partial response divided by the number of randomized patients.
Overall survival: Overall survival time will be calculated from the date of randomization until death due to any cause.
Safety assessments: Data on vital signs, physical examination, adverse events, serum chemistry, hematological laboratory tests, and electrocardiograms will be collected.
Based on the data for irinotecan, it is estimated that the median PFS in the second-line chemotherapy arm will be 4 months. In order to demonstrate an improvement in median PFS to 5.5 months (37.5% improvement, hazard ratio of 0.73) based on a two-sided log rang test, 338 patients (169 per arm) will be required, assuming an 18 month enrollment and a 12 month follow-up, an alpha of 0.05 and 90% power. The sample size assumes a 10% loss to follow-up rate.
A futility analysis will be performed when 33% of the events required for the final analysis have occurred by an Independent Data Monitoring Committee. The futility boundary will be described in the full statistical analysis plan for the study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Gastric Cancer|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT01070290|
|Other Study ID Numbers ICMJE||ARQ 197-206|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Study Sponsor ICMJE||ArQule|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Verification Date||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP