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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02532868
Recruitment Status : Terminated
First Posted : August 26, 2015
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.

Condition or disease Intervention/treatment Phase
Cancer Drug: MK-0457 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: MK-0457
Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV.
Drug: MK-0457
Other Name: VX-680 (an Aurora Kinase Inhibitor)

Primary Outcome Measures :
  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans [ Time Frame: Predose, and at end of Cycles 2 and 6 (up to approximately 4 months) ]
  2. Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Pre-dose through post-study visit (up to 3 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02532868

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02532868     History of Changes
Obsolete Identifiers: NCT00104351
Other Study ID Numbers: 0457-002
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015