NCT00405054

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 leukemia

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2.5 years

First QC Date

November 28, 2006

Last Update Submit

January 23, 2015

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • efficacy

    24 Months

Study Arms (1)

1

OTHER

continuous infusion every 14 days

Drug: MK0457

Interventions

MK0457DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. Blood Cancer J. 2014 Aug 15;4(8):e238. doi: 10.1038/bcj.2014.60.

    PMID: 25127392RESULT

MeSH Terms

Conditions

Leukemia

Interventions

tozasertib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

December 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 26, 2015

Record last verified: 2015-01