Expired Study
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Durham, North Carolina


Purpose:

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.


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).


NCT ID:

NCT00544960


Primary Contact:

Study Chair
Lance Leopold, MD
Ascenta Therapeutics, Inc.


Backup Contact:

N/A


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: November 21, 2017

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