Back to resultsPhase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Primary Purpose
Myelogenous Leukemia, Chronic
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SCH66336
Sponsored by
About this trial
This is an interventional treatment trial for Myelogenous Leukemia, Chronic focused on measuring Philadelphia chromosome positive CML, Myelogenous Leukemia, Chronic, Chronic Phase, Myelogenous Leukemia, Chronic, Accelerated Phase
Eligibility Criteria
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.
Sites / Locations
- MDAnderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00038597
First Posted
June 3, 2002
Last Updated
October 29, 2018
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00038597
Brief Title
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Official Title
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2001 (Actual)
Primary Completion Date
May 7, 2004 (Actual)
Study Completion Date
May 7, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelogenous Leukemia, Chronic
Keywords
Philadelphia chromosome positive CML, Myelogenous Leukemia, Chronic, Chronic Phase, Myelogenous Leukemia, Chronic, Accelerated Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SCH66336
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cortes, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDAnderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website
Learn more about this trial
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
We'll reach out to this number within 24 hrs