Back to resultsMultiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MPC-6827
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring Metastases, Refractory, Brain
Eligibility Criteria
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
Sites / Locations
- MD Anderson Cancer Center
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Pharmacokinetics
Secondary Outcome Measures
Antitumor Activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00393965
Brief Title
Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Myrexis Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Metastases, Refractory, Brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MPC-6827
Intervention Description
2-hour IV infusion given once weekly for 3 consecutive weeks on a 28-day cycle.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
1 year
Title
Pharmacokinetics
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Antitumor Activity
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Yu, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
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