Status:
COMPLETED
Phase 1 Study of MKC-1 in Patients With Advanced Cancer
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.
Eligibility Criteria
Inclusion
- Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
- Age greater than or equal to 18 years.
- ECOG performance status ≤1
- ANC greater than or equal to 1,500/mm3;
- Platelets greater than or equal to 100,000/mm3
- creatinine ≤1.5 times institutional upper limit of normal (ULN)
- T Bili within normal limits;
- AST and ALT less than or equal to 2.5 times ULN; and
- albumin greater than or equal to 3.0 g/dL
- have measurable disease by RECIST, radiographically evaluable disease, or detectable disease
- women of child-bearing potential and men must agree to use adequate contraception
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Have previously received MKC-1.
- Have received radiation to greater than 25% of the bone marrow.
- Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Are concurrently receiving any other investigational agents while on study.
- Have known brain metastases
- Have any condition that impairs the ability to swallow and retain MKC-1 capsules.
- Uncontrolled intercurrent illness
- Are pregnant or breastfeeding
- HIV-positive patients
- Patients with uncontrolled diabetes
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00656461
Start Date
March 1 2008
End Date
November 1 2009
Last Update
November 25 2009
Active Locations (1)
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1
U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792