MK0457 in Patients With Leukemia - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00111683

Purpose

This is an open-label trial of an investigational drug to treat relapsed/refractory leukemia.

Condition	Intervention	Phase
Chronic Myelogenous Leukemia in Blast Crisis Lymphocytic Leukemia, B Cell, Acute Myelodysplastic Syndromes Myelogenous Leukemia, Chronic	Drug: MK0457	Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of MK0457 as 5 day infusion measured by duration, grade, and time of onset of toxicity. Plasma pK levels by dose level. [ Time Frame: 30 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy (i.e. hematological response). Measurement: Patients will be assessed for efficacy at the end of each treatment cycle based on hematological response criteria. [ Time Frame: 30 Months ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	June 2005
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 MK0457	Drug: MK0457 IV infusion at rising dose levels of 2, 4, 8, 12, 16, 20 and 24 mg/m2/hour; 5-day continuous infusion every 21 days for 30 Months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111683

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_033, MK0457-003
Study First Received:	May 24, 2005
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00111683
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Myelodysplastic Syndrome[Refractory Anemia with
Excess Blasts-1 or 2 (WHO Classification)]
Chronic Myelogenous Leukemia in blast crisis

Study placed in the following topic categories:

Myelodysplastic syndromes
Blast Crisis
Leukemia, Lymphoid
Immunoproliferative Disorders
Chronic myelogenous leukemia
Precancerous Conditions
Refractory anemia
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Anemia

Myeloproliferative Disorders
Leukemia, Myeloid
Lymphatic Diseases
Leukemia
Preleukemia
Anemia, Refractory
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Leukemia, B-Cell
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Disease
Pathologic Processes

Neoplasms by Histologic Type
Immune System Diseases
Syndrome
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on January 16, 2009