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

G

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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