Metastatic Melanoma
Conditions
Keywords
Melanoma, Metastatic
Brief summary
This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.
Interventions
DRUGMPC-6827 + Temozolomide
MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Temozolomide at 85 mg/m2 administered orally daily for 21 days in a 4 week cycle.
Sponsors
Myrexis Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven melanoma * For subjects with brain metastases that require radiation, therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug * Have unresectable melanoma with measurable metastases * Be a minimum of 4 weeks since prior surgical resection or major surgical procedure and a minimum of 2 weeks since chemotherapy/ biochemotherapy * Performance score of Karnofsky ≥ 60%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2, or WHO ≤ 2 * If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week
Exclusion criteria
* Hypersensitivity to Cremophor EL * Have current/active intratumor hemorrhage by CT/MRI within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI * Have ocular melanoma * Have primary intradural melanoma or leptomeningeal involvement * Have cardiovascular disease (unstable angina or MI) * Have cerebrovascular disease (stroke and/or TIA) * Have uncontrolled hypertension * Have a cardiac ejection fraction \< 50% * Have Troponin-I elevated above the normal range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability; Maximum Tolerated Dose | After each cohort is enrolled |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Cycle 1 |
| Antitumor Activity | Screening, end of each cycle, end of study |
Countries
United States
Outcome results
None listed