Back to resultsPhase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Primary Purpose
Metastatic Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MPC-6827 + Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, Metastatic
Eligibility Criteria
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
Sites / Locations
- The Angeles Clinic
- Cancer Centers of Florida
- Cancer Centers of the Carolinas
- University of Texas MD Anderson Cancer Center
- Huntsman Cancer Institute at the University of Utah
Outcomes
Primary Outcome Measures
Safety and Tolerability; Maximum Tolerated Dose
Secondary Outcome Measures
Pharmacokinetics
Antitumor Activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00609011
Brief Title
Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Official Title
Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Myrexis Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MPC-6827 + Temozolomide
Intervention Description
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 Outcome Measure Information:
Title
Safety and Tolerability; Maximum Tolerated Dose
Time Frame
After each cohort is enrolled
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
Cycle 1
Title
Antitumor Activity
Time Frame
Screening, end of each cycle, end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew P. Beelen, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Angeles Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Cancer Centers of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
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