Clinical Trials
Non-Small Cell Lung Cancer (NSCLC) Clinical Trials
Trial Number—AT-101-CS-204
A randomized, double-blind phase II trial comparing the safety and efficacy of the combination of AT-101 and docetaxel with docetaxel alone in patients with relapsed/refractory non-small cell lung cancer.
Primary Objective
- To estimate and compare the progression-free survival of AT-101 combined with docetaxel versus docetaxel alone
Secondary Objective
- To evaluate the safety of AT-101 and docetaxel and secondary efficacy measure
Key Inclusion Criteria
- Adults with histologically or cytologically confirmed Stage IIIb non-small cell lung cancer or Stage IV non-small cell lung cancer
- Progression of disease after 1 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 1 prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- 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 to 2
- Adequate hematologic, liver, and renal function
- Ability to swallow oral medication
Key Exclusion Criteria
- Patients with unstable or progressive brain metastases are not eligible.
- Prior chemotherapy regimen containing docetaxel
- Active secondary malignancy
- Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure, 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 (eg, surgery, radiation, chemotherapy)
Location and Contact Information
For more information on this trial, please contact Mr. Wood or Dr. Leopold using the information provided below.
Brian Wood (610) 408-0301 bwood@ascenta.com
Lance Leopold, MD (610) 408-0301 lleopold@ascenta.com
This study is currently being conducted at study sites within the United States, Russia, and Ukraine.
Trial Identification Number
NCT00544960