Cancer
Conditions
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.
Interventions
DRUGMK-0457
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Outcome results
None listed