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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Mark Berger, MD
Gemin X, Inc.
United States: Food and Drug Administration
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|