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

NCT ID: NCT00397293

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-12-31

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:

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascenta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Ascenta Therapeutics, Inc.

Principal Investigators

Lance Leopold, MD

Role: STUDY_CHAIR

Ascenta Therapeutics, Inc.

Locations

Birmingham, Alabama, United States

Hot Springs, Arkansas, United States

Loma Linda, California, United States

Stamford, Connecticut, United States

Jacksonville, Florida, United States

Lake City, Florida, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

Lebanon, New Hampshire, United States

High Point, North Carolina, United States

Portland, Oregon, United States

Columbia, South Carolina, United States

Hilton Head Island, South Carolina, United States

Germantown, Tennessee, United States

Austin, Texas, United States

Burlington, Vermont, United States

Huntington, West Virginia, United States

Research Center (16)

Russia, Russia, Russia

Research Centers (8)

Ukraine, Ukraine, Ukraine

Countries

United States; Russia; Ukraine

Other Identifiers

AT-101-CS-101

Identifier Type: -

Identifier Source: org_study_id