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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

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: NCT00405951
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: Obatoclax mesylate 250 ml Drug: Docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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)
Study Start Date : October 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Obatoclax Mesylate + Docetaxel
Obatoclax Mesylate 250mL in combination with Docetaxel
Drug: Obatoclax mesylate 250 ml
Drug: Docetaxel

Primary Outcome Measures :
  1. 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 :
  1. Peripheral blood counts; Bone marrow aspirates and biopsies [ Time Frame: 18 months ]

Information from the National Library of Medicine

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

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

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): NCT00405951

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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
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Study Director: Jean Viallet, MD Gemin X Pharmaceuticals

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Responsible Party: Gemin X Identifier: NCT00405951     History of Changes
Other Study ID Numbers: GEM010
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors