A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)
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
2 other identifiers
interventional
27
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started May 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedAugust 26, 2015
August 1, 2015
2.7 years
July 18, 2014
August 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Up to 21 days
Secondary Outcomes (2)
Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans
Predose, and at end of Cycles 2 and 6 (up to approximately 4 months)
Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST)
Pre-dose through post-study visit (up to 3 years)
Study Arms (1)
MK-0457
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20386909DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2014
First Posted
August 26, 2015
Study Start
May 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
August 26, 2015
Record last verified: 2015-08