Back to resultsDiflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Diflomotecan (BN80915)
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00080015
Brief Title
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2004 (Actual)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diflomotecan (BN80915)
Primary Outcome Measure Information:
Title
Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary Outcome Measure Information:
Title
Time to tumour progression
Title
Time to treatment failure
Title
Duration of overall response
Title
Overall complete response, partial response and stable disease
Title
Time to response
Title
Six month and one year survival rates
Title
Median survival
Title
Best overall response
Title
Overall objective response rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
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