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

Completed · Phase 1/Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00397293

Run by

Ascenta Therapeutics

People needed

36

Starts

2006-11-01

Expected to finish

2008-12-01

Last updated by the study team

2010-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Loma Linda, California, United States
• Study site — Stamford, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lake City, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — High Point, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Columbia, South Carolina, United States
• Study site — Hilton Head Island, South Carolina, United States
• Study site — Germantown, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Huntington, West Virginia, United States
• Research Center (16) — Russia, Russia, Russia
• Research Centers (8) — Ukraine, Ukraine, Ukraine

Full record on ClinicalTrials.gov

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