- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00038597
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
October 29, 2018 updated by: M.D. Anderson Cancer Center
The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML.
The safety of this treatment will also be studied.
Study Overview
Detailed Description
Objectives for this study are two-fold:
- To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.
- To assess the toxicity of SCH66366 in these patients.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
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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Texas
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Houston, Texas, United States, 77030
- MDAnderson 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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;
- Failure to respond to or intolerance to imatinib mesylate (Gleevec);
- Age >/= 16 years;
- Life expectancy of >/= 2 months;
- Performance status 2 or better (Zubrod);
- Adequate renal and hepatic functions (creatinine and bilirubin </= 2 mg/dl);
- Adequate cardiac function;
- Not candidates for or have refused allogeneic transplantation;
- Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.
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)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jorge Cortes, MD, UT MD Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Actual)
April 30, 2001
Primary Completion (Actual)
May 7, 2004
Study Completion (Actual)
May 7, 2004
Study Registration Dates
First Submitted
June 3, 2002
First Submitted That Met QC Criteria
June 3, 2002
First Posted (Estimate)
June 4, 2002
Study Record Updates
Last Update Posted (Actual)
October 30, 2018
Last Update Submitted That Met QC Criteria
October 29, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM01-072
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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