Phase 1 Study of MKC-1 in Patients With Advanced Cancer
NCT ID: NCT00656461
Last Updated: 2009-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2008-03-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
Interventions
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MKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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CASI Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Miikana Therapeutics, an EntreMed, Inc. company
Principal Investigators
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Glenn Liu, MD
Role: PRINCIPAL_INVESTIGATOR
U. of Wisconsin
Locations
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U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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MKC-106
Identifier Type: -
Identifier Source: org_study_id