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

NCT00609011 | Completed Phase 1

• 1 other identifier: MPC-6827-07-005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Melanoma

Keywords

Melanoma; Metastatic

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability; Maximum Tolerated Dose

  After each cohort is enrolled

Secondary Outcomes (2)

• Pharmacokinetics

  Cycle 1

• Antitumor Activity

  Screening, end of each cycle, end of study

Interventions

MPC-6827 + Temozolomide DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (5)

The Angeles Clinic

Los Angeles, California, 90025, United States

Location

Cancer Centers of Florida

Ocoee, Florida, 34761, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

verubulin; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew P. Beelen, MD

  Myrexis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

US (5)