Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma

Myrexis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Metastatic Melanoma

Treatments

Drug: MPC-6827 + Temozolomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00609011

MPC-6827-07-005

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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