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A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

Thank you

Trial Information

A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mark Berger, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM303

NCT ID:

NCT00724841

Start Date:

June 2008

Completion Date:

August 2010

Related Keywords:

  • Metastatic Melanoma
  • Melanoma

Name

Location
University of Pennsylvania Philadelphia, Pennsylvania  19104