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A Study of MK0731 in Patients With Advanced Solid Tumors (0731-002)(COMPLETED)

An Open-label, Dose Escalation Phase I/II Trial of a KSP Inhibitor Given as a Constant 24-Hour Infusion in Patients With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104364
Enrollment
30
Registered
2005-02-28
Start date
2005-05-31
Completion date
2008-01-31
Last updated
2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

The purpose of this trial is to study MK0731 in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Interventions

DRUGMK0731

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for whom standard therapy does not exist. Part of the study includes only patients who have taxane-resistant cancers.

Exclusion criteria

* Patients who have had treatment with any investigational therapy within the past 30 days. * Patients who have certain types of blood cancers such as leukemia or lymphoma. * Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation. * Patient is pregnant or nursing.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability of MK0731 administered as a 24-hour CIV Infusion. Dose limiting toxicities. Maximum tolerated dose and recommended Phase II dose of L-001154704 administered as a 24 hour CIV infusion.

Secondary

MeasureTime frame
Predose predictive biomarkers of response to MK0731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026