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

July 19, 2016 updated by: Gemin X

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic College of Medicine
    • California
      • Beverly Hills, California, United States, 90210
        • Tower Oncology
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21225
        • Medstar Research Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Peripheral blood counts; Bone marrow aspirates and biopsies
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemin X

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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