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

Ascenta Therapeutics2 sites in 2 countries36 target enrollmentNovember 2006

ConditionsSmall Cell Lung Cancer

DrugsAT-101 topotecan

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Small Cell Lung Cancer
Sponsor: Ascenta Therapeutics
Enrollment: 36
Locations: 2
Primary Endpoint: Number of participants with adverse events.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

December 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ascenta Therapeutics

Eligibility Criteria

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).