Back to resultsA Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
Primary Purpose
Metastatic Melanoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Obatoclax Mesylate
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic melanoma
- Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
- Normal organ and marrow function
- Willing to submit to blood sampling for planned PK/PD analyses
- Ability of understand and willingness to sign a written informed consent
Exclusion Criteria:
- No other investigational or commercial agents or therapies
- Prior exposure to GMX1777, GMX1778 or CHS828
- Patients with uncontrolled, intercurrent illness
- Pregnant or breastfeeding women
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
40 mg/m2 GMX1777 with Temozolomide
50 mg/m2 GMX1777 with Temozolomide
62 mg/m2 GMX1777 with Temozolomide
80 mg/m2 GMX1777 with Temozolomide
100 mg/m2 GMX1777 with Temozolomide
125 mg/m2 GMX1777 with Temozolomide
Outcomes
Primary Outcome Measures
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Secondary Outcome Measures
Learn more about how the body processes GMX1777
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724841
Brief Title
A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
Official Title
A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated prematurely due to financial contraints.
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2010 (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
Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
Detailed Description
GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
40 mg/m2 GMX1777 with Temozolomide
Arm Title
2
Arm Type
Experimental
Arm Description
50 mg/m2 GMX1777 with Temozolomide
Arm Title
3
Arm Type
Experimental
Arm Description
62 mg/m2 GMX1777 with Temozolomide
Arm Title
4
Arm Type
Experimental
Arm Description
80 mg/m2 GMX1777 with Temozolomide
Arm Title
5
Arm Type
Experimental
Arm Description
100 mg/m2 GMX1777 with Temozolomide
Arm Title
6
Arm Type
Experimental
Arm Description
125 mg/m2 GMX1777 with Temozolomide
Intervention Type
Drug
Intervention Name(s)
Obatoclax Mesylate
Other Intervention Name(s)
GMX1777
Intervention Description
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Primary Outcome Measure Information:
Title
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Time Frame
2 years
Title
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Time Frame
Within the first 4 weeks
Title
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Time Frame
Within the first 8 weeks
Secondary Outcome Measure Information:
Title
Learn more about how the body processes GMX1777
Time Frame
Within the fisrt 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed metastatic melanoma
Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
Normal organ and marrow function
Willing to submit to blood sampling for planned PK/PD analyses
Ability of understand and willingness to sign a written informed consent
Exclusion Criteria:
No other investigational or commercial agents or therapies
Prior exposure to GMX1777, GMX1778 or CHS828
Patients with uncontrolled, intercurrent illness
Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Berger, MD
Organizational Affiliation
Gemin X, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
We'll reach out to this number within 24 hrs