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

NCT00724841 | Terminated Phase 1

• 1 other identifier: GEM303
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (3)

• Determine the recommended Phase II dose of GMX1777 in combination with temozolomide

  2 years

• Learn more about the side effects of taking GMX1777 in combination with temozolomide

  Within the first 4 weeks

• Determine the disease response to treatment with GMX1777 in combination with temozolomide

  Within the first 8 weeks

Secondary Outcomes (1)

• Learn more about how the body processes GMX1777

  Within the fisrt 30 days

Study Arms (6)

1

EXPERIMENTAL

40 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

2

EXPERIMENTAL

50 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

3

EXPERIMENTAL

62 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

4

EXPERIMENTAL

80 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

5

EXPERIMENTAL

100 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

6

EXPERIMENTAL

125 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate; Drug: Temozolomide

Interventions

Obatoclax Mesylate DRUG

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

Also known as: GMX1777

1; 2; 3; 4; 5; 6

Temozolomide DRUG

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gemin X: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

obatoclax; 1-(2-(2-(2-(2-methoxyethoxy)ethoxy)ethoxy)ethoxycarbonyloxymethyl)-4-(N'-cyano-N''-(6-(4-chlorophenoxy)hexyl)-N-guanidino)pyridinium; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Berger, MD

  Gemin X, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2010
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

US (1)