Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
Information source: Ascenta Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Small Cell Lung Cancer
Intervention: AT-101 (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Ascenta Therapeutics Official(s) and/or principal investigator(s):
Lance Leopold, MD, Study Chair, Affiliation: Ascenta Therapeutics, Inc.
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
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety of AT-101 in combination with topotecan.
Secondary outcome: Preliminary efficacy of AT-101 in combination with topotecan.
Detailed description:
Further Study Details provided by Ascenta:
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Research Center (16), Russia, Russian Federation
Research Centers (8), Ukraine, Ukraine
Birmingham, Alabama 35233, United States
Hot Springs, Arkansas, United States
Loma Linda, California 92354, United States
Stamford, Connecticut, United States
Lake City, Florida, United States
Jacksonville, Florida, United States
Boston, Massachusetts 02114, United States
Rochester, Minnesota 55905, United States
Lebanon, New Hampshire, United States
High Point, North Carolina, United States
Portland, Oregon 97213, United States
Columbia, South Carolina, United States
Hilton Head Island, South Carolina, United States
Germantown, Tennessee, United States
Austin, Texas 78705, United States
Burlington, Vermont 05405, United States
Huntington, West Virginia, United States
Additional Information
Starting date: November 2006
Ending date: November 2008
Last updated: April 30, 2008
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