NCT00104364

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started May 2005

Status
completed

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

February 25, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

February 25, 2005

Last Update Submit

January 29, 2015

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Predose predictive biomarkers of response to MK0731

Interventions

MK0731DRUG

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.1007/s10637-011-9653-1. Epub 2011 Mar 22.

    PMID: 21424701RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

4-(2,5-difluorophenyl)-N-(3-fluoro-1-methylpiperidin-4-yl)-2-(hydroxymethyl)-N-methyl-2-phenyl-2,5-dihydro-1H-pyrrole-1-carboxamide

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2005

First Posted

February 28, 2005

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 30, 2015

Record last verified: 2015-01