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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00405054
• Other study ID #: 0457-008
• Secondary ID: MK0457-0082006_5
• Status: Terminated
• Phase: Phase 2
• First received: November 28, 2006
• Last updated: January 23, 2015
• Start date: December 2006
• Est. completion date: June 2009

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• MK0457
IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Seymour JF, Kim DW, Rubin E, Haregewoin A, Clark J, Watson P, Hughes T, Dufva I, Jimenez JL, Mahon FX, Rousselot P, Cortes J, Martinelli G, Papayannidis C, Nagler A, Giles FJ. A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelog — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy		24 Months	No