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

Ascenta Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Small Cell Lung Cancer

Treatments

Drug: AT-101

Drug: topotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00397293

AT-101-CS-101

Details and patient eligibility

About

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

Full description

Further Study Details provided by Ascenta:

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).