Clinical Trials Directory

Trials / Completed

CompletedNCT00080015

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

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.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Ipsen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDiflomotecan (BN80915)

Timeline

Start date
2004-03-12
Primary completion
2005-02-01
Completion
2005-02-01
First posted
2004-03-23
Last updated
2020-04-29

Source: ClinicalTrials.gov record NCT00080015. Inclusion in this directory is not an endorsement.