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COMPLETEDPHASE1/PHASE2

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

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy

NCT00397293•Ascenta Therapeutics

View on ClinicalTrials.gov

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:

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (19)

Birmingham, Alabama, United States

Hot Springs, Arkansas, United States

Loma Linda, California, United States

Stamford, Connecticut, United States

Jacksonville, Florida, United States

Lake City, Florida, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

Lebanon, New Hampshire, United States

High Point, North Carolina, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

August 24, 2010

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

AT-101

DRUG

topotecan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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