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

Sponsor:	Myrexis Inc.
Information provided by:	Myrexis Inc.
ClinicalTrials.gov Identifier:	NCT00609011

Purpose

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	Intervention	Phase
Metastatic Melanoma	Drug: MPC-6827 + Temozolomide	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:

Safety and Tolerability; Maximum Tolerated Dose [ Time Frame: After each cohort is enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
Antitumor Activity [ Time Frame: Screening, end of each cycle, end of study ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	March 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609011

Locations

United States, California
The Angeles Clinic
Los Angeles, California, United States, 90025
United States, Florida
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
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.

More Information

No publications provided

Responsible Party:	Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00609011 History of Changes
Other Study ID Numbers:	MPC-6827-07-005
Study First Received:	January 23, 2008
Last Updated:	August 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:

Melanoma
Metastatic

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012