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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00111683
Other study ID # 0457-003
Secondary ID 2005_033
Status Completed
Phase Phase 1
First received May 24, 2005
Last updated August 21, 2015
Start date June 2005
Est. completion date May 2008

Study information

Verified date August 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MK0457


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 l — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) Part 1: up to 5 days, Part 2: up to 24 hours Yes
Secondary Hematological response rate to MK-0457 as a 5-day CIV infusion At the end of each cycle (up to 18 months) No
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