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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Cancer

Treatments: Drug: MK-0457

Study type: Interventional

Funder types: Industry

Identifiers

NCT02532868

2005_005

0457-002

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

MK-0457

Experimental group

Description:

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.

Treatment:

Drug: MK-0457