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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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Obatoclax mesylate 250 ml
Docetaxel
Sponsored by
Gemin X
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic College of Medicine
  • Tower Oncology
  • Georgetown University
  • H. Lee Moffitt Cancer Center
  • University of Maryland
  • MedStar Research Institute
  • Arlington Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obatoclax Mesylate + Docetaxel

Arm Description

Obatoclax Mesylate 250mL in combination with Docetaxel

Outcomes

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
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

Full Information

First Posted
November 30, 2006
Last Updated
July 19, 2016
Sponsor
Gemin X
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1. Study Identification

Unique Protocol Identification Number
NCT00405951
Brief Title
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemin X

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obatoclax Mesylate + Docetaxel
Arm Type
Experimental
Arm Description
Obatoclax Mesylate 250mL in combination with Docetaxel
Intervention Type
Drug
Intervention Name(s)
Obatoclax mesylate 250 ml
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
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
Description
Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Peripheral blood counts; Bone marrow aspirates and biopsies
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Viallet, MD
Organizational Affiliation
Gemin X Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic College of Medicine
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Tower Oncology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
MedStar Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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