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

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00397293
First received: November 7, 2006
Last updated: August 20, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: AT-101
Drug: topotecan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • Number of participants with adverse events. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complete or partial remission of disease [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.
Detailed Description:

Further Study Details provided by Ascenta:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397293

  Show 19 Study Locations
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
Study Chair: Lance Leopold, MD Ascenta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Janet Maleski, Associate Director, Clinical Development, Ascenta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00397293     History of Changes
Other Study ID Numbers: AT-101-CS-101
Study First Received: November 7, 2006
Last Updated: August 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
AT101
AT-101
cancer
lung
small-cell
topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gossypol
Gossypol acetic acid
Topotecan
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Spermatocidal Agents
Antispermatogenic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014