Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)(TERMINATED) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 1, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	June 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)(TERMINATED)
Official Title ^ICMJE	Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia
Brief Summary	The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Condition ^ICMJE	Leukemia Myelodysplastic Syndromes Leukemia, Myeloid, Chronic Blast Crisis Leukemia, Lymphocytic
Intervention ^ICMJE	Drug: Farnesyl Protein Transferase Inhibitor
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	90
Completion Date	March 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia. Life expectancy of 12 weeks or greater. ECOG Performance Status less than or equal to 2. Meets protocol requirements for specified laboratory values. No manifestations of a malabsorption syndrome. Exclusion Criteria: Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease. Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions. Patients who have received investigational therapy of any type within 30 days prior to administration.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00034684
Responsible Party
Study ID Numbers ^ICMJE	P00701
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP