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Completed

NCT Number: NCT00393965

Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases

Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Refractory Brain Metastases
  • At least 1 measurable intracranial lesion as defined by RECIST
  • ECOG less than or equal to 1
  • Adequate hematology/organ function
  • No baseline peripheral or central neuropathy above grade 1

Exclusion criteria

  • Hypersensitivity to Cremophor EL
  • Pregnant or Lactating
  • Spinal Cord Compression
  • Pre-existing dementia/cognitive disfunction
  • Require Neupogen or Neulasta to Maintain Neutrophil Count
  • Have Primary Brain Cancer
  • Have History of Ischemic Heart Disease
  • Have Diabetes

Treatment and study plan

MPC-6827

Drug

2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 1 year

  2. Pharmacokinetics

    Time frame: 1 year

Secondary outcomes

  1. Antitumor Activity

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Myrexis Inc.

Industry

Registry information

Official study title

Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 31, 2006
Registry last updated
Feb 13, 2008

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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