MK0457 in Patients With Leukemia (0457-003)

NCT00111683 | Completed Phase 1

• 2 other identifiers: 0457-0032005_033
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

  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

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

Study Arms (1)

MK-0457

EXPERIMENTAL

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

Drug: MK0457

Interventions

MK0457 DRUG

MK-0457

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 leukemia. Leukemia. 2013 Jan;27(1):113-7. doi: 10.1038/leu.2012.186. Epub 2012 Jul 9.

  PMID: 22772060 RESULT

MeSH Terms

Conditions

Leukemia, Lymphoid; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

tozasertib

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2005
• First Posted: May 25, 2005
• Study Start: June 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 25, 2015

Record last verified: 2015-08