CClinicalTrials.gg
TerminatedNCT00405054Updated Jan 26, 2015

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

A Phase 2 interventional study of MK0457 in Leukemia, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Leukemia

Browse trials for

03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 52 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Other
    1

    continuous infusion every 14 days

    Drug: MK0457

Interventions

  • DrugMK0457

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

06

What researchers measure

Primary outcomes

  1. efficacy

    Time frame: 24 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25127392 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00405054
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 29, 2006
Start date
Dec 2006
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jan 26, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion