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

• Sponsor: Myrexis Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00609011
• Collaborator: (none)
• Enrollment: 22
• Locations: 5
• Duration (Months): 17
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Drug: MPC-6827 + Temozolomide	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability; Maximum Tolerated Dose [After each cohort is enrolled]

Secondary Outcome Measures

1. Pharmacokinetics [Cycle 1]

2. Antitumor Activity [Screening, end of each cycle, end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic	Los Angeles	California	United States	90025
2	Cancer Centers of Florida	Ocoee	Florida	United States	34761
3	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605
4	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Myrexis Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00609011
• Other Study ID Numbers: MPC-6827-07-005
• First Posted: Feb 6, 2008
• Last Update Posted: Aug 23, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Melanoma; Metastatic
• Additional relevant MeSH terms: Melanoma; Temozolomide

Study Results

No Results Posted as of Aug 23, 2010