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

August 20, 2010 updated by: Ascenta Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Small Cell Lung Cancer

Intervention / Treatment

Detailed Description

Further Study Details provided by Ascenta:

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Russian Federation
- - Russia, Russian Federation
    - Research Center (16)
Ukraine
- - Ukraine, Ukraine
    - Research Centers (8)
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
- Arkansas
  - Hot Springs, Arkansas, United States
- California
  - Loma Linda, California, United States, 92354
- Connecticut
  - Stamford, Connecticut, United States
- Florida
  - Jacksonville, Florida, United States
  - Lake City, Florida, United States
- Massachusetts
  - Boston, Massachusetts, United States, 02114
- Minnesota
  - Rochester, Minnesota, United States, 55905
- New Hampshire
  - Lebanon, New Hampshire, United States
- North Carolina
  - High Point, North Carolina, United States
- Oregon
  - Portland, Oregon, United States, 97213
- South Carolina
  - Columbia, South Carolina, United States
  - Hilton Head Island, South Carolina, United States
- Tennessee
  - Germantown, Tennessee, United States
- Texas
  - Austin, Texas, United States, 78705
- Vermont
  - Burlington, Vermont, United States, 05405
- West Virginia
  - Huntington, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events. Time Frame: 13 months	13 months

Secondary Outcome Measures

Outcome Measure	Time Frame
complete or partial remission of disease Time Frame: 16 months	16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascenta Therapeutics

Investigators

Study Chair: Lance Leopold, MD, Ascenta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)