A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)(TERMINATED)

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00104351

First received: February 25, 2005

Last updated: May 23, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: VX-680 (an Aurora Kinase Inhibitor)	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	26
Study Start Date:	May 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 MK0457	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104351

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00104351 History of Changes
Other Study ID Numbers:	2005_005, MK0457-002
Study First Received:	February 25, 2005
Last Updated:	May 23, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013

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