MK0457 in Patients With Leukemia (0457-003)

NCT ID: NCT00111683

Last Updated: 2015-08-25

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

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-05-31

Brief Summary

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In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.

Detailed Description

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Conditions

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Chronic Myelogenous Leukemia in Blast Crisis Lymphocytic Leukemia, B Cell, Acute Myelodysplastic Syndromes Myelogenous Leukemia, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-0457

Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration

Group Type EXPERIMENTAL

MK0457

Intervention Type DRUG

Interventions

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MK0457

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Part 1:

* Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis

Part 2:

* Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
* At least 2 weeks since the last cytotoxic therapy
* Acceptable renal and hepatic function
* Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
* More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

Exclusion Criteria

* Not fully recovered from previous anti-leukemia therapy
* Previous allogeneic bone marrow transplant
* Uncontrolled congestive heart failure
* Myocardial infarction within the last 3 months
* Active or uncontrolled infection
* Pregnancy or lactation
* Currently active second malignancy, other than non-melanoma skin cancer
* History of hepatitis B or C, known HIV positivity, or AIDS related illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Giles FJ, Swords RT, Nagler A, Hochhaus A, Ottmann OG, Rizzieri DA, Talpaz M, Clark J, Watson P, Xiao A, Zhao B, Bergstrom D, Le Coutre PD, Freedman SJ, Cortes JE. MK-0457, an Aurora kinase and BCR-ABL inhibitor, is active in patients with BCR-ABL T315I leukemia. Leukemia. 2013 Jan;27(1):113-7. doi: 10.1038/leu.2012.186. Epub 2012 Jul 9.

Reference Type RESULT
PMID: 22772060 (View on PubMed)

Other Identifiers

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2005_033

Identifier Type: -

Identifier Source: secondary_id

0457-003

Identifier Type: -

Identifier Source: org_study_id

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