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

Study Overview
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Brief Summary
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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
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Further Study Details provided by Ascenta:

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: AT-101
* Drug: topotecan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AT-101|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.|
|Drug: topotecan|40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events. |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete or partial remission of disease |  | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AT101, AT-101, cancer, lung, small-cell, topotecan