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NCT Number: NCT00609011

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Angeles Clinic, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety and Tolerability; Maximum Tolerated Dose

    Time frame: After each cohort is enrolled

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Cycle 1

  2. Antitumor Activity

    Time frame: Screening, end of each cycle, end of study

Sponsors and collaborators

Lead sponsor

Myrexis Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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