A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
18 Years
N/A
Both
Small Cell Lung Cancer
Trial Information
A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
Main
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall objective response rate (tumour assessments should be performed every 6 weeks)
Principal Investigator
Thierry Le Chevalier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Gustave Roussy, Villejuif, Paris, France
Authority:
United States: Food and Drug Administration
Study ID:
2-91-52990-708
NCT ID:
NCT00080015
Start Date:
March 2004
Completion Date:
February 2005
Related Keywords:
- Small Cell Lung Cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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