Melanoma Clinical Trial

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

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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.

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Full 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.

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Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00724841

Recruitment Status:

Terminated

Sponsor:

Gemin X

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There is 1 Location for this study

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University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00724841

Recruitment Status:

Terminated

Sponsor:


Gemin X

How clear is this clinincal trial information?

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