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A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Ascenta Therapeutics
Information provided by: Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00544960
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: AT-101 and docetaxel
Drug: placebo and docetaxel
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:   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)

Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • To estimate and compare the progression free survival (PFS) of AT-101 in combination with docetaxel with docetaxel and placebo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of AT-101 in combination with docetaxel and secondary efficacy measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   102
Study Start Date:   September 2007
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
AT-101 and docetaxel
Drug: 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 Comparator
placebo and docetaxel
Drug: 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

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 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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544960

Locations
United States, North Carolina
Research Site    
      Durham, North Carolina, United States
Russian Federation
Research Site    
      Arkhangelsk, Russian Federation
Research Site    
      Chelyabinsk, Russian Federation
Research Site    
      Ekaterinburg, Russian Federation
Research Site    
      Samara, Russian Federation
Research Site    
      Kazan, Russian Federation
Research Site    
      Moscow, Russian Federation
Research Sites (4)    
      Saint Petersburg, Russian Federation
Research Site    
      Kaliningrad, Russian Federation
Research Site    
      Stavropol, Russian Federation
Research Site    
      Voronezh, Russian Federation
Ukraine
Research Site    
      Dnipropetrovsk, Ukraine
Research Site    
      Donetsk, Ukraine
Research Site    
      Lugansk, Ukraine
Research Site    
      Zaporizhzhya, Ukraine
Research Site    
      Kharkiv, Ukraine
Research Site    
      Uzhgorod, Ukraine
Research Site    
      Kyiv, Ukraine

Sponsors and Collaborators
Ascenta Therapeutics

Investigators
Study Chair:     Lance Leopold, MD     Ascenta Therapeutics, Inc.    
  More Information

Responsible Party:   Ascenta Therapeutics ( Brian Wood, Associate Director, Clinical Development )
Study ID Numbers:   AT-101-CS-204
First Received:   October 12, 2007
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00544960
Health Authority:   United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
gossypol  
AT101  
AT-101  
cancer  
lung
non-small cell
docetaxel
bcl

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gossypol
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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