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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104364
• Other study ID #: 0731-002
• Secondary ID: 2005_004
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2005
• Last updated: January 29, 2015
• Start date: May 2005
• Est. completion date: January 2008

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• MK0731

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Holen K, DiPaola R, Liu G, Tan AR, Wilding G, Hsu K, Agrawal N, Chen C, Xue L, Rosenberg E, Stein M. A phase I trial of MK-0731, a kinesin spindle protein (KSP) inhibitor, in patients with solid tumors. Invest New Drugs. 2012 Jun;30(3):1088-95. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predose predictive biomarkers of response to MK0731