Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00034684
NCT00034684CompletedPhase 1

Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia

Merck Sharp & Dohme LLC0 sites132 target enrollmentStarted: July 2001Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
132
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Terminated
Phase 1
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)Neoplasms
NCT00040534Merck Sharp & Dohme LLC22
Completed
Phase 1
Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)Neoplasms
NCT00040547Merck Sharp & Dohme LLC29
Unknown
Phase 1
Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)Cancer
NCT00006199National Center for Research Resources (NCRR)
Terminated
Phase 2
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)Carcinoma, Squamous CellHead and Neck Neoplasms
NCT00073450Merck Sharp & Dohme LLC15
Completed
Phase 2
Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's DiseaseMild Cognitive ImpairmentAlzheimer's Disease
NCT01661673FORUM Pharmaceuticals Inc52