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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: AT-101 and docetaxel; Drug: placebo and docetaxel

• Registration Number: NCT00544960
• Lead Sponsor: Ascenta Therapeutics

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-12
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-16
• Primary Completion: 2008-11
• Study Completion: 2009-04
• Status Verified: 2010-08
• Disposition First Submitted: 2010-08-12
• Disposition First Submitted QC: 2010-08-12
• Disposition First Posted: 2010-08-17
• Last Update Submitted: 2010-08-24
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AT-101 and docetaxel	AT-101 and docetaxel
2	placebo and docetaxel	placebo and docetaxel

Primary Outcome Measures

Name	Time	Method
duration of disease remission	12 months

Secondary Outcome Measures

Name	Time	Method
number of participants with adverse events	12 months

Trial Locations

Locations (2)

Research Sites (4); 🇷🇺 Saint Petersburg, Russian Federation

Research Site; 🇺🇦 Zaporizhzhya, Ukraine