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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-05-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myelogenous Leukemia, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SCH66336

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No