COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544960
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : August 27, 2010
Information provided by:
Ascenta Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: AT-101 and docetaxel Drug: placebo and docetaxel Phase 2

Detailed Description:
Further Study Details provided by Ascenta.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. duration of disease remission [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. number of participants with adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544960

Layout table for location information
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
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
Layout table for investigator information
Study Chair: Lance Leopold, MD Ascenta Therapeutics, Inc.

Layout table for additonal information
Responsible Party: Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics Identifier: NCT00544960    
Other Study ID Numbers: AT-101-CS-204
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010
Keywords provided by Ascenta Therapeutics:
non-small cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action