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CompletedNCT00111683Updated Aug 25, 2015

MK0457 in Patients With Leukemia (0457-003)

A Phase 1 interventional study of MK0457 in Chronic Myelogenous Leukemia in Blast Crisis, Lymphocytic Leukemia, B Cell, Acute and Myelodysplastic Syndromes, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

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

Keywords

  • Myelodysplastic Syndrome[Refractory Anemia with
  • Excess Blasts-1 or 2 (WHO Classification)]
  • Chronic Myelogenous Leukemia in blast crisis
03

In context

Leukemia, Lymphoid

1,772 studies on the registry are indexed under Leukemia, Lymphoid; 173 are open to participants now.

This study's enrollment of 28 is below the median of 36 across 1,410 interventional studies indexed under Leukemia, Lymphoid.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    MK-0457

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

    Drug: MK0457

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Time frame: Part 1: up to 5 days, Part 2: up to 24 hours

Secondary outcomes

  1. Hematological response rate to MK-0457 as a 5-day CIV infusion

    Time frame: At the end of each cycle (up to 18 months)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 22772060 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2005
First posted
May 25, 2005
Start
Jun 2005
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Aug 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00111683
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 25, 2005
Start date
Jun 2005
Primary completion
May 2008
Completion
May 2008
Last update
Aug 25, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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