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

This study has been terminated.

First Received: February 25, 2005 Last Updated: December 20, 2007 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00104351

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 I

MedlinePlus related topics: Cancer

Drug Information available for: VX-680

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:	November 2007

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.

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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_005, MK0457-002
Study First Received:	February 25, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00104351 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009