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)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Dose Escalation of MK0457 in Combination With Dasatinib in Patients With Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Conditions
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Chronic Myelogenous Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Intervention / Treatment
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* Drug: MK0457
* Drug: dasatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Arm A: Drug and comparator | Drug: MK0457<br>* 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.<br>Drug: dasatinib<br>* Oral dasatinib 70 mg b.i.d. tablets twice daily.<br>* Other names: Sprycel®;|
| Other: B<br>Arm B: Drug and comparator | Drug: MK0457<br>* 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.<br>Drug: dasatinib<br>* Oral dasatinib 70 mg b.i.d. tablets twice daily.<br>* Other names: Sprycel®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics, Safety, Tolerability |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability |  | 28 Days |