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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02532868
• Other study ID #: 0457-002
• Secondary ID: 2005_005
• Status: Terminated
• Phase: Phase 1
• First received: July 18, 2014
• Last updated: August 25, 2015
• Start date: May 2005
• Est. completion date: January 2008

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• MK-0457

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)		Up to 21 days	Yes
Secondary	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)	No
Secondary	Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST)		Pre-dose through post-study visit (up to 3 years)	No