Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: June 3, 2002
Last updated: January 20, 2012
Last verified: January 2012
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.
Myelogenous Leukemia, Chronic
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2004 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038597
|MDAnderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Jorge Cortes, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 3, 2002
||January 20, 2012
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Philadelphia chromosome positive CML
Myelogenous Leukemia, Chronic, Chronic Phase
Myelogenous Leukemia, Chronic, Accelerated Phase
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases