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

NCT ID: NCT02532868

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MK-0457

Intervention Type DRUG

Interventions

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MK-0457

Intervention Type DRUG

Other Intervention Names

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VX-680 (an Aurora Kinase Inhibitor)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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. doi: 10.1007/s00280-010-1318-9. Epub 2010 Apr 13.

Reference Type DERIVED
PMID: 20386909 (View on PubMed)

Other Identifiers

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2005_005

Identifier Type: -

Identifier Source: secondary_id

0457-002

Identifier Type: -

Identifier Source: org_study_id

NCT00104351

Identifier Type: -

Identifier Source: nct_alias

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