A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)

A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00405054

Enrollment

Registered

2006-11-29

Start date

2006-12-31

Completion date

2009-06-30

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Brief summary

This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.

Interventions

DRUGMK0457

IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia) * Patients must have adequate organ function * Patients must have documented T315I mutation

Exclusion criteria

* Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy * Patients with uncontrolled congestive heart failure * Patients with active or uncontrolled infection or active Hepatitis B or C * Patients with known HIV positivity or AIDS related illness * Patients with currently active second malignancy, other than non-melanoma skin cancer.

Design outcomes

Primary

Measure	Time frame
efficacy	24 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026