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Trial record 4 of 6 for:    azixa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00609011
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Myrexis Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date August 23, 2010
Study Start Date  ICMJE March 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
Safety and Tolerability; Maximum Tolerated Dose [ Time Frame: After each cohort is enrolled ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Maximum Tolerated Dose [ Time Frame: 8 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • Pharmacokinetics [ Time Frame: Cycle 1 ]
  • Antitumor Activity [ Time Frame: Screening, end of each cycle, end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
  • Pharmacokinetics [ Time Frame: 8 months ]
  • Antitumor Activity [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Official Title  ICMJE Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE Drug: MPC-6827 + Temozolomide
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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2009)
22
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2008)
16
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00609011
Other Study ID Numbers  ICMJE MPC-6827-07-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew P. Beelen, MD / Sr. Director of Clinical Research, Myriad Pharmaceuticals
Study Sponsor  ICMJE Myrexis Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew P. Beelen, MD Myrexis Inc.
PRS Account Myrexis Inc.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP