Status:
COMPLETED
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Ipsen
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pati...
Eligibility Criteria
Inclusion
- Main
- 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
- Uncontrollable brain metastasis
- Treated with an investigational drug within 30 days
Key Trial Info
Start Date :
March 12 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00080015
Start Date
March 12 2004
End Date
February 1 2005
Last Update
April 29 2020
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