A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00500006

Purpose

This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Efficacy and Safety will be evaluated.

Condition	Intervention	Phase
Chronic Myelogenous Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive	Drug: MK0457 Drug: dasatinib	Phase I

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

Drug Information available for: Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I Dose Escalation of MK0457 in Combination With Dasatinib in Patients With Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Further study details as provided by Merck:

Primary Outcome Measures:

Pharmacokinetics, Safety, Tolerability [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Arm A: Drug and comparator	Drug: MK0457 Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour. Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour. Drug: dasatinib Oral dasatinib 70 mg b.i.d. tablets twice daily.
B Arm B: Drug and comparator	Drug: MK0457 Schedule A: 5-day continuous IV infusion every 28 days MK0457 (dose determined by height and weight). Starting dose = 20 mg/m2/hour titrating up to 33 mg/m2/hour. Schedule B: 6-hr IV infusion every 14 days MK0457 (dose determined by height and weight). Starting dose = 64 mg/m2/hour titrating up to 216 mg/m2/hour. Drug: dasatinib Oral dasatinib 70 mg b.i.d. tablets twice daily.

Eligibility

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

Criteria

Inclusion Criteria:

Patients must have chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
Patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for CML or Ph+ ALL and be evaluable for hematologic response prior to entering the study
Patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry
Patients with active CNS disease are included and may be treated concurrently with intrathecal therapy as per institutional standards

Exclusion Criteria:

Patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. Pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility
Patient has unresolved more than or equal to grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry
Patient has known hypersensitivity to the components of study drug or its analogs
Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
Patient has symptomatic ascites, pericardial or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible
Patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy
Patient has a LVEF <40% by multigated radionucleotide angiography (MUGA) or echocardiography

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500006

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:	2007_509, MK0457-009
Study First Received:	July 10, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00500006
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chromosomal abnormalities
Philadelphia Chromosome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid

Leukemia
Lymphatic Diseases
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Lymphoproliferative Disorders
Bone Marrow Diseases
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

ClinicalTrials.gov processed this record on January 14, 2009