Chronic Myelogenous Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Conditions
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.
Interventions
DRUGMK0457
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.
DRUGdasatinib
Oral dasatinib 70 mg b.i.d. tablets twice daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, Safety, Tolerability | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability | 28 Days |
Outcome results
None listed