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

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00544960
First received: October 12, 2007
Last updated: August 24, 2010
Last verified: August 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • duration of disease remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of participants with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kaliningrad, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Sites (4)
Saint Petersburg, Russian Federation
Research Site
Samara, Russian Federation
Research Site
Stavropol, Russian Federation
Research Site
Voronezh, Russian Federation
Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Uzhgorod, Ukraine
Research Site
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
Study Chair: Lance Leopold, MD Ascenta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00544960     History of Changes
Other Study ID Numbers: AT-101-CS-204
Study First Received: October 12, 2007
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gossypol
Gossypol acetic acid
Docetaxel
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Spermatocidal Agents
Antispermatogenic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014