MK0457 in Patients With Leukemia (0457-003)

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK0457

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia in Blast Crisis focused on measuring Myelodysplastic Syndrome[Refractory Anemia with, Excess Blasts-1 or 2 (WHO Classification)], Chronic Myelogenous Leukemia in blast crisis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MK-0457

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00111683

First Posted

May 24, 2005

Last Updated

August 21, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00111683

Brief Title

MK0457 in Patients With Leukemia (0457-003)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK-0457

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MK0457

Primary Outcome Measure Information:

Title

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

22772060

Citation

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.

Results Reference

result

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial