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
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 |
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.
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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 |
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