Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT00397293
• Lead Sponsor: Ascenta Therapeutics

Brief Summary

This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer

Detailed Description

Further Study Details provided by Ascenta:

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• 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: 2010-08-20
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
• Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
• All patients must have measurable disease.
• 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

• Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
• Prior chemotherapy regimen containing irinotecan.
• Active secondary malignancy.
• Unstable or progressive brain metastases.
• Prior history of radiation therapy to > 25% of the bone marrow.
• 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: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events.	13 months

Secondary Outcome Measures

Name	Time	Method
complete or partial remission of disease	16 months

Trial Locations

Locations (2)

Research Center (16); 🇷🇺 Russia, Russian Federation

Research Centers (8); 🇺🇦 Ukraine, Ukraine

Research Center (16)

🇷🇺Russia, Russian Federation