Status:
COMPLETED
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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:
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00397293
Start Date
November 1 2006
End Date
December 1 2008
Last Update
August 24 2010
Active Locations (19)
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1
Birmingham, Alabama, United States, 35233
2
Hot Springs, Arkansas, United States
3
Loma Linda, California, United States, 92354
4
Stamford, Connecticut, United States