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

Gemin X

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Melanoma

Treatments: Drug: Obatoclax Mesylate; Drug: Temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724841

GEM303

Details and patient eligibility

About

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.

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 6 patient groups

1

Experimental group

Description:

40 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate

2

Experimental group

Description:

50 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate

3

Experimental group

Description:

62 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate

4

Experimental group

Description:

80 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate

5

Experimental group

Description:

100 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate

6

Experimental group

Description:

125 mg/m2 GMX1777 with Temozolomide

Treatment:

Drug: Temozolomide

Drug: Obatoclax Mesylate