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Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
This study has been completed.
First Received: November 7, 2006   Last Updated: April 28, 2009   History of Changes
Sponsored by: Ascenta Therapeutics
Information provided by: Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00397293
  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
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:
  • Safety of AT-101 in combination with topotecan. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary efficacy of AT-101 in combination with topotecan. [ 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.
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
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: Ascenta Therapeutics, Inc. ( Janet Maleski, Associate Director, Clinical Development )
Study ID Numbers: AT-101-CS-101
Study First Received: November 7, 2006
Last Updated: April 28, 2009
ClinicalTrials.gov Identifier: NCT00397293     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Gossypol acetic acid
Gossypol
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Retinol acetate
Neuroepithelioma
Topotecan
Adenocarcinoma
Acetic Acid
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Contraceptive Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Gossypol
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antispermatogenic Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Gossypol acetic acid
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Topotecan

ClinicalTrials.gov processed this record on September 01, 2009