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)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 1

Conditions

Chronic Myelogenous Leukemia

Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Treatments

Drug: dasatinib

Drug: MK0457

Study type

Interventional

Funder types

Industry

Identifiers

NCT00500006

0457-009

2007_509

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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