- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00544960
A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer
August 24, 2010 updated by: Ascenta Therapeutics
A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Further Study Details provided by Ascenta.
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkhangelsk, Russian Federation
- Research Site
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Chelyabinsk, Russian Federation
- Research Site
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Ekaterinburg, Russian Federation
- Research Site
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Kaliningrad, Russian Federation
- Research Site
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Kazan, Russian Federation
- Research Site
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Moscow, Russian Federation
- Research Site
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Saint Petersburg, Russian Federation
- Research Sites (4)
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Samara, Russian Federation
- Research Site
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Stavropol, Russian Federation
- Research Site
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Voronezh, Russian Federation
- Research Site
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Dnipropetrovsk, Ukraine
- Research Site
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Donetsk, Ukraine
- Research Site
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Kharkiv, Ukraine
- Research Site
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Kyiv, Ukraine
- Research Site
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Lugansk, Ukraine
- Research Site
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Uzhgorod, Ukraine
- Research Site
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Zaporizhzhya, Ukraine
- Research Site
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North Carolina
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Durham, North Carolina, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
- 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:
- Prior chemotherapy regimen containing docetaxel.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
AT-101 and docetaxel
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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
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Placebo Comparator: 2
placebo and docetaxel
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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duration of disease remission
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants with adverse events
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lance Leopold, MD, Ascenta Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 12, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 16, 2007
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 24, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- AT-101-CS-204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on AT-101 and docetaxel
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University of Michigan Rogel Cancer CenterCompletedLaryngeal CancerUnited States
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Ascenta TherapeuticsCompletedHormone Refractory Prostate CancerUnited States, Russian Federation
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Ralexar Therapeutics, Inc.CompletedAtopic Dermatitis | Eczema, AtopicUnited States
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H. Lee Moffitt Cancer Center and Research InstituteMinneamrita Therapeutics LLCTerminatedAcute Myeloid LeukemiaUnited States
-
Ascenta TherapeuticsCompletedFollicular LymphomaUnited States
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Aclaris Therapeutics, Inc.CompletedSeborrheic Keratosis (SK)United States
-
Scioderm, Inc.Amicus TherapeuticsCompletedEpidermolysis BullosaUnited States
-
University of Alabama at BirminghamAscenta TherapeuticsWithdrawnCarcinoma, Non Small Cell Lung
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Ascenta TherapeuticsCompletedSmall Cell Lung CancerUnited States, Russian Federation, Ukraine