Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC) - Tabular View

Tracking Information

First Received Date ^ICMJE

March 19, 2004

Last Updated Date

July 23, 2009

Start Date ^ICMJE

March 2004

Primary Completion Date

February 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall objective response rate (tumour assessments should be performed every 6 weeks)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00080015 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)

Official Title ^ICMJE

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.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Diflomotecan (BN80915)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

February 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00080015

Responsible Party

Study ID Numbers ^ICMJE

2-91-52990-708

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thierry Le Chevalier, MD

Institut Gustave Roussy, Villejuif, Paris, France

Information Provided By

Ipsen

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP