MK0457 in Patients With Leukemia (0457-003) | NCT00111683

Studies
MK0457 in Patients With Leukemia (0457-003)

NCT00111683

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Aug 25, 2015Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

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

Interventions

MK0457

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005_033

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

May 24, 2005

First Submission Date that Met QC Criteria

May 24, 2005

First Posted Date

May 25, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Label	Type	Description	Intervention Names
MK-0457	Experimental	Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration	Drug: MK0457

Name	Type	Description	Arm Group Labels	Other Names
MK0457	Drug		MK-0457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)		Part 1: up to 5 days, Part 2: up to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Hematological response rate to MK-0457 as a 5-day CIV infusion		At the end of each cycle (up to 18 months)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22772060	Result	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.

ID	Term
D007945	Leukemia, Lymphoid
D009190	Myelodysplastic Syndromes
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

ID	Term
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases