MK0457 in Patients With Leukemia (0457-003)

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

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

• Blast Crisis
• Chronic Myelogenous Leukemia in Blast Crisis
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Lymphocytic Leukemia, B Cell, Acute
• Myelodysplastic Syndromes
• Myelogenous Leukemia, Chronic
• Preleukemia

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