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

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma

In brief

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.

Key facts

Study ID

NCT00724841

Run by

Gemin X

People needed

1

Starts

2008-06-01

Expected to finish

2010-08-01

Last updated by the study team

2016-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No other investigational or commercial agents or therapies
• Prior exposure to GMX1777, GMX1778 or CHS828
• Patients with uncontrolled, intercurrent illness
• Pregnant or breastfeeding women

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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