Status:
TERMINATED
A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
Lead Sponsor:
Gemin X
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 varie...
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, o...
Eligibility Criteria
Inclusion
- 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
- No other investigational or commercial agents or therapies
- Prior exposure to GMX1777, GMX1778 or CHS828
- Patients with uncontrolled, intercurrent illness
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00724841
Start Date
June 1 2008
End Date
August 1 2010
Last Update
July 22 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104