Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina


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

Study summary:

Further Study Details provided by Ascenta.


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).



Primary Contact:

Study Chair
Lance Leopold, MD
Ascenta Therapeutics, Inc.

Backup Contact:


Location Contact:

Durham, North Carolina
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.