Overview
MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)
Status:
Completed
Completed
Trial end date:
2008-12-01
2008-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Merck Sharp & Dohme Corp.
Criteria
Inclusion Criteria:- Patients must be at least 18 years of age, with adequate organ function, and an ECOG
performance of <2
- Patients must be willing to undergo pre-study and post dose tumor biopsy and have
tumor accessible to biopsy (waived during Part A)
Exclusion Criteria:
- No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study
participation
- Patients must not have primary central nervous system tumor
- Patient has had prescription or non-prescription drugs or other products known to be
metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and
withheld throughout the study until 2 weeks after the last dose of study medication