A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
- 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
- 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,