- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111683
MK0457 in Patients With Leukemia (0457-003)
August 21, 2015 updated by: Merck Sharp & Dohme LLC
A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MK-0457
Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time Frame: Part 1: up to 5 days, Part 2: up to 24 hours
|
Part 1: up to 5 days, Part 2: up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hematological response rate to MK-0457 as a 5-day CIV infusion
Time Frame: At the end of each cycle (up to 18 months)
|
At the end of each cycle (up to 18 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (ACTUAL)
May 1, 2008
Study Completion (ACTUAL)
May 1, 2008
Study Registration Dates
First Submitted
May 24, 2005
First Submitted That Met QC Criteria
May 24, 2005
First Posted (ESTIMATE)
May 25, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 21, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Precancerous Conditions
- Leukemia, Lymphoid
- Cell Transformation, Neoplastic
- Carcinogenesis
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Preleukemia
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Leukemia, B-Cell
Other Study ID Numbers
- 0457-003
- 2005_033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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