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Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038597
First Posted: June 4, 2002
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention Phase
Myelogenous Leukemia, Chronic Drug: SCH66336 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 13
Study Start Date: April 2001
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Objectives for this study are two-fold:

  1. 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.
  2. To assess the toxicity of SCH66366 in these patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038597


Locations
United States, Texas
MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jorge Cortes, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038597     History of Changes
Other Study ID Numbers: DM01-072
First Submitted: June 3, 2002
First Posted: June 4, 2002
Last Update Posted: January 23, 2012
Last Verified: January 2012

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:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes
Lonafarnib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action