Non-small Cell Lung Cancer
Conditions
Keywords
AT101, AT-101, cancer, lung, non-small cell, docetaxel, bcl
Brief 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
Detailed description
Further Study Details provided by Ascenta.
Interventions
DRUGAT-101 and docetaxel
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
DRUGplacebo and docetaxel
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
Sponsors
Ascenta Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of disease remission | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with adverse events | 12 months |
Countries
Russia, Ukraine, United States
Outcome results
None listed