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NCT00080015 Clinical Trial

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

Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00080015
Other study ID # 2-91-52990-708
Secondary ID 2004-001350-92
Status Completed
Phase Phase 2
First received
Last updated
Start date March 12, 2004
Est. completion date February 2005

Study information
Verified date April 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Diflomotecan (BN80915)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Outcome
Type Measure Description Time frame Safety issue
Primary Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary Time to tumour progression
Secondary Time to treatment failure
Secondary Duration of overall response
Secondary Overall complete response, partial response and stable disease
Secondary Time to response
Secondary Six month and one year survival rates
Secondary Median survival
Secondary Best overall response
Secondary Overall objective response rate
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