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

November 7, 2006
August 20, 2010
November 2006
December 2008   (final data collection date for primary outcome measure)
Number of participants with adverse events. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
Safety of AT-101 in combination with topotecan.
Complete list of historical versions of study NCT00397293 on ClinicalTrials.gov Archive Site
complete or partial remission of disease [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Preliminary efficacy of AT-101 in combination with topotecan.
Not Provided
Not Provided
 
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
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

Further Study Details provided by Ascenta:

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2008
December 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Ukraine
 
NCT00397293
AT-101-CS-101
No
Janet Maleski, Associate Director, Clinical Development, Ascenta Therapeutics, Inc.
Ascenta Therapeutics
Not Provided
Study Chair: Lance Leopold, MD Ascenta Therapeutics, Inc.
Ascenta Therapeutics
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP