Status:
COMPLETED
Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments
Lead Sponsor:
Myrexis Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future. The study drug is designed to reduce the activity of a protein k...
Detailed Description
This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.
Eligibility Criteria
Inclusion
- recurrent cancer refractory to available systemic therapy
- 18 years old or older
- predicted life expectancy equal or greater to 8 weeks
- at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
- Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
- adequate organ function based on hematological, liver, and renal function
- LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
- wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued
Exclusion
- pregnant or breastfeeding
- received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
- symptoms of heart failure equal or greater to Class III (by NYHA criteria)
- impaired cardiac function or clinically significant cardiac diseases
- concurrent treatment with medications that either markedly induce or inhibit CYP3A4
- concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00920205
Start Date
June 1 2009
End Date
June 1 2011
Last Update
October 14 2011
Active Locations (3)
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1
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229