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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397293
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : August 24, 2010
Information provided by:
Ascenta Therapeutics

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: AT-101 Drug: topotecan Phase 1 Phase 2

Detailed Description:
Further Study Details provided by Ascenta:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Number of participants with adverse events. [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. complete or partial remission of disease [ Time Frame: 16 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397293

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

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Responsible Party: Janet Maleski, Associate Director, Clinical Development, Ascenta Therapeutics, Inc. Identifier: NCT00397293    
Other Study ID Numbers: AT-101-CS-101
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010
Keywords provided by Ascenta Therapeutics:
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gossypol acetic acid
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male