A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

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

Details

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).

• Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.

• All patients must have measurable disease.

• No unstable or progressive brain metastases.

• 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:

• Prior chemotherapy regimen containing docetaxel.

• Active secondary malignancy.

• 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).