Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

Phase 1

Completed

• Conditions: Chronic Myelogenous Leukemia
• Interventions: Drug: Lonafarnib (SCH66336); Drug: Imatinib Mesylate (Gleevec)

• Registration Number: NCT00047502
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.

Detailed Description

Existing pre-clinical and clinical data suggest that SCH66336, a farnesyl transferase inhibitor,exhibits significant activity against CML cells, and in fact may have synergistic activity in combination with imatinib mesylate. Thus, the objectives to the study are (1) to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of lonafarnib (SCH66336), a farnesyl transferase inhibitor, in combination with imatinib mesylate (Gleevec) in patients with chronic phase, accelerated phase, and blast crisis CML; (2) to assess the pharmacokinetics of the combination of lonafarnib and Gleevec in these patients; and (3) to assess in a preliminary way the biologic activity of the combination of lonafarnib and Gleevec in these patients.

Study Timeline

• Study First Submitted: 2002-10-08
• Study First Submitted QC: 2002-10-08
• Study First Posted: 2002-10-09
• Study Start: 2002-11-01
• Primary Completion: 2006-04-10
• Study Completion: 2006-04-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gleevec + SCH 66336	Imatinib Mesylate (Gleevec)	Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.
Gleevec + SCH 66336	Lonafarnib (SCH66336)	Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	3 months	Dose-Limiting Toxicity (DLT) defined as grade 3 or 4 non-hematologic toxicity (NCI common criteria, version 2.0). Grade 3 or 4 nausea and vomiting considered DLT only if uncontrolled by antiemetics. Grade 3 or 4 diarrhea considered DLT only if uncontrolled for 48 hours despite adequate antidiarrheal therapy.

Trial Locations

Locations (1)

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States