Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Farnesyl Protein Transferase Inhibitor

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Leukemia, Lymphocytic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00034684

First Posted

May 1, 2002

Last Updated

June 16, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00034684

Brief Title

Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2001 (undefined)

Primary Completion Date

October 2003 (Actual)

Study Completion Date

October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic, Blast Crisis, Leukemia, Lymphocytic

Keywords

Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Leukemia, Lymphocytic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Farnesyl Protein Transferase Inhibitor

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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