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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.
First Received: October 12, 2007   Last Updated: December 4, 2008   History of Changes
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

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)

Resource links provided by NLM:


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

No publications provided

Responsible Party: Ascenta Therapeutics ( Brian Wood, Associate Director, Clinical Development )
Study ID Numbers: AT-101-CS-204
Study First Received: October 12, 2007
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00544960     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Thoracic Neoplasms
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Gossypol acetic acid
Gossypol
Carcinoma
Docetaxel
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Retinol acetate
Non-small Cell Lung Cancer
Acetic Acid
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Gossypol acetic acid
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Antispermatogenic Agents
Spermatocidal Agents
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009