- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656461
Phase 1 Study of MKC-1 in Patients With Advanced Cancer
November 23, 2009 updated by: CASI Pharmaceuticals, Inc.
Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
Time Frame: Throughout study participation
|
Throughout study participation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.
Time Frame: During study participation
|
During study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glenn Liu, MD, U. of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
April 7, 2008
First Submitted That Met QC Criteria
April 7, 2008
First Posted (Estimate)
April 11, 2008
Study Record Updates
Last Update Posted (Estimate)
November 25, 2009
Last Update Submitted That Met QC Criteria
November 23, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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