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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609011
• Other study ID #: MPC-6827-07-005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 23, 2008
• Last updated: August 19, 2010
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2010
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• MPC-6827 + Temozolomide
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.

Locations

Country	Name	City	State
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	The Angeles Clinic	Los Angeles	California
United States	Cancer Centers of Florida	Ocoee	Florida
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability; Maximum Tolerated Dose		After each cohort is enrolled	Yes
Secondary	Pharmacokinetics		Cycle 1	No
Secondary	Antitumor Activity		Screening, end of each cycle, end of study	No