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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-08-31

Brief Summary

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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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Detailed Description

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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

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Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

40 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

2

50 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

3

62 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

4

80 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

5

100 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

6

125 mg/m2 GMX1777 with Temozolomide

Group Type EXPERIMENTAL

Obatoclax Mesylate

Intervention Type DRUG

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Temozolomide

Intervention Type DRUG

Interventions

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Obatoclax Mesylate

Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide

Intervention Type DRUG

Temozolomide

Intervention Type DRUG

Other Intervention Names

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GMX1777

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No