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

A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma

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.

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.

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