A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)

Phase 1

Terminated

• Conditions: Chronic Myelogenous Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
• Interventions: Drug: MK0457; Drug: dasatinib

• Registration Number: NCT00500006
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Study Start: 2007-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	MK0457	Arm A: Drug and comparator
B	MK0457	Arm B: Drug and comparator
A	dasatinib	Arm A: Drug and comparator
B	dasatinib	Arm B: Drug and comparator

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics, Safety, Tolerability	28 Days

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability	28 Days