A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)
- Registration Number
- NCT02532868
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-0457 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.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) Up to 21 days
- Secondary Outcome Measures
Name Time Method 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)