Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascenta Therapeutics
• Treatments: Gossypol; Gossypol acetic acid; Topotecan

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.

• Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan

• All patients must have measurable disease.

• Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.

• ECOG performance status 0-1

• Adequate hematologic function

• Adequate liver and renal function

• Ability to swallow oral medication

Exclusion Criteria:

• Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.

• Prior chemotherapy regimen containing irinotecan.

• Active secondary malignancy.

• Unstable or progressive brain metastases.

• Prior history of radiation therapy to > 25% of the bone marrow.

• Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.

• Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).