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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Time frame: 2 years
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Time frame: Within the first 4 weeks
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Time frame: Within the first 8 weeks
Learn more about how the body processes GMX1777
Time frame: Within the fisrt 30 days
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