A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X
• Treatments: Dacarbazine; Obatoclax; Temozolomide

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