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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00405054
First received: November 28, 2006
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Leukemia
 Drug: MK0457
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • efficacy [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
continuous infusion every 14 days
 Drug: MK0457
IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405054

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00405054     History of Changes
Other Study ID Numbers: 2006_551, MK0457-008
Study First Received: November 28, 2006
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013