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

Ipsen

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Diflomotecan (BN80915)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080015

2-91-52990-708

2004-001350-92 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)