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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and Tolerability; Maximum Tolerated Dose

Outcome Time Frame:

After each cohort is enrolled

Safety Issue:

Yes

Principal Investigator

Andrew P. Beelen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-6827-07-005

NCT ID:

NCT00609011

Start Date:

March 2008

Completion Date:

August 2009

Related Keywords:

  • Metastatic Melanoma
  • Melanoma
  • Metastatic
  • Melanoma

Name

Location

Cancer Centers of the Carolinas Greenville, South Carolina  29605
Cancer Centers of Florida Orlando, Florida  32806
University of Texas MD Anderson Cancer Center Houston, Texas  77030
The Angeles Clinic Santa Monica, California  90404
Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah  84112