A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer
NCT ID: NCT00544960
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2007-09-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
AT-101 and docetaxel
AT-101 and docetaxel
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
2
placebo and docetaxel
placebo and docetaxel
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
Interventions
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AT-101 and docetaxel
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
placebo and docetaxel
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
Eligibility Criteria
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Inclusion Criteria
* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
* All patients must have measurable disease.
* No unstable or progressive brain metastases.
* 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
* Active secondary malignancy.
* 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).
18 Years
ALL
No
Sponsors
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Ascenta Therapeutics
INDUSTRY
Responsible Party
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Ascenta Therapeutics
Principal Investigators
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Lance Leopold, MD
Role: STUDY_CHAIR
Ascenta Therapeutics, Inc.
Locations
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Research Site
Durham, North Carolina, United States
Research Site
Arkhangelsk, , Russia
Research Site
Chelyabinsk, , Russia
Research Site
Kaliningrad, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Sites (4)
Saint Petersburg, , Russia
Research Site
Samara, , Russia
Research Site
Stavropol, , Russia
Research Site
Voronezh, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Luhansk, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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AT-101-CS-204
Identifier Type: -
Identifier Source: org_study_id
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