A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Ascenta Therapeutics2 sites in 2 countries106 target enrollmentSeptember 2007

ConditionsNon-small Cell Lung Cancer

InterventionsAT-101 and docetaxel placebo and docetaxel

DrugsAT-101 and docetaxel placebo and docetaxel

Overview

Phase: Phase 2
Intervention: AT-101 and docetaxel
Conditions: Non-small Cell Lung Cancer
Sponsor: Ascenta Therapeutics
Enrollment: 106
Locations: 2
Primary Endpoint: duration of disease remission
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

April 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Ascenta Therapeutics

Eligibility 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).