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

August 19, 2010 updated by: Myrexis Inc.

Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide

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.

Study Overview

Status

Completed

Conditions

Metastatic Melanoma

Intervention / Treatment

Drug: MPC-6827 + Temozolomide

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90025
    - The Angeles Clinic
- Florida
  - Ocoee, Florida, United States, 34761
    - Cancer Centers of Florida
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas
- Texas
  - Houston, Texas, United States, 77030
    - University of Texas MD Anderson Cancer Center
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute at the University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability; Maximum Tolerated Dose Time Frame: After each cohort is enrolled	After each cohort is enrolled

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics Time Frame: Cycle 1	Cycle 1
Antitumor Activity Time Frame: Screening, end of each cycle, end of study	Screening, end of each cycle, end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myrexis Inc.

Investigators

Study Director: Andrew P. Beelen, MD, Myrexis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria