Status:
TERMINATED
Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer
Lead Sponsor:
Myriad Therapeutics, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
Detailed Description
MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progress...
Eligibility Criteria
Inclusion
- Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study related procedures;
- Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
- Have measurable or evaluable neoplastic disease;
- Be greater than or equal to age 18;
- Have and ECOG Performance Status score of less than or equal to 2;
- Have adequate organ function defined by:
- Liver function tests (AST \& ALT) less than or equal to 3 times the upper limit of normal (ULN);
- Bilirubin less than or equal to 1.5 X ULN;
- Serum Creatinine less than or equal to 1.5 X ULN;
- Hemoglobin greater than or equal to 8.0 g/dL;
- Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
- Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.
Exclusion
- Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
- Be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records);
- Receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (LHRH) therapy while in this study;
- Have previously enrolled in this trial. -
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00387153
Start Date
August 1 2005
End Date
October 1 2006
Last Update
November 3 2009
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030