NCT00724841

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Obatoclax Mesylate	Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
DRUG	Temozolomide

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-07-01
• Completion: 2010-08-01
• First posted: 2008-07-30
• Last updated: 2016-07-22

Locations

1 site across 1 country: United States