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Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405951
First Posted: December 4, 2006
Last Update Posted: July 21, 2016
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
  Purpose

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.


Condition Intervention Phase
Lung Cancer Drug: Obatoclax mesylate 250 ml Drug: Docetaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Gemin X ):

Primary Outcome Measures:
  • RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension [ Time Frame: 18 months ]
    Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.


Secondary Outcome Measures:
  • Peripheral blood counts; Bone marrow aspirates and biopsies [ Time Frame: 18 months ]

Enrollment: 47
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obatoclax Mesylate + Docetaxel
Obatoclax Mesylate 250mL in combination with Docetaxel
Drug: Obatoclax mesylate 250 ml Drug: Docetaxel

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC)
  • Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations
  • Must have normal organ function
  • Must be willing to submit to blood sampling for planned PK and PD analysis
  • Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

  • No other agents or therapies administered with the intent to treat malignancy
  • Patients with prior exposure to obatoclax or docetaxel
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00405951


Locations
United States, Arizona
Mayo Clinic College of Medicine
Scottsdale, Arizona, United States, 85259
United States, California
Tower Oncology
Beverly Hills, California, United States, 90210
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
MedStar Research Institute
Baltimore, Maryland, United States, 21225
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Jean Viallet, MD Gemin X Pharmaceuticals
  More Information

Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00405951     History of Changes
Other Study ID Numbers: GEM010
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action