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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

continuous infusion every 14 days

Group Type OTHER

MK0457

Intervention Type DRUG

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

Interventions

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MK0457

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No