A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00104351

First received: February 25, 2005

Last updated: January 25, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2005

Last Updated Date

January 25, 2010

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of a 24 hour CIV infusion every 21 days [ Time Frame: Trial Duration ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

proprietary information - exploratory (non-confirmatory) trial

Change History

Complete list of historical versions of study NCT00104351 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate radiologic response and pharmacodynamic biomarker response to treatment [ Time Frame: Trial Duration ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

proprietary information - exploratory (non-confirmatory) trial

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer

Official Title ^ICMJE

A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer

Brief Summary

The purpose of this trial is to study an investigational drug in patients with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: VX-680 (an Aurora Kinase Inhibitor)

24 hr CIV infusion at rising dose levels of 2, 4, 8, 16, 32 and 64 mg/m2/hour; 5-day continuous infusion every 21 days.

Other Name: MK0457

Study Arm (s)

MK0457

Intervention: Drug: VX-680 (an Aurora Kinase Inhibitor)

Publications *

Traynor AM, Hewitt M, Liu G, Flaherty KT, Clark J, Freedman SJ, Scott BB, Leighton AM, Watson PA, Zhao B, O'Dwyer PJ, Wilding G. Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Feb;67(2):305-14. Epub 2010 Apr 13.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00104351

Other Study ID Numbers ^ICMJE

2005_005, MK0457-002

Has Data Monitoring Committee

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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