A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

Ascenta Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: placebo and docetaxel; Drug: AT-101 and docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544960

AT-101-CS-204

Details and patient eligibility

About

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

Full description

Further Study Details provided by Ascenta.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AT-101 and docetaxel

Treatment:

Drug: AT-101 and docetaxel

2

Placebo Comparator group

Description:

placebo and docetaxel

Treatment:

Drug: placebo and docetaxel