Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
Phase 2
Completed
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT00080015
- Lead Sponsor
- Ipsen
- Brief Summary
This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Documented small cell lung cancer (SCLC)
- Measurable disease
- One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months
Main
Exclusion Criteria
- Uncontrollable brain metastasis
- Treated with an investigational drug within 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall objective response rate (tumour assessments should be performed every 6 weeks)
- Secondary Outcome Measures
Name Time Method Time to tumour progression Time to treatment failure Duration of overall response Overall complete response, partial response and stable disease Time to response Six month and one year survival rates Median survival Best overall response Overall objective response rate