Trial Information
A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety and tolerability of MK2461
Outcome Time Frame:
18 Months
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_530
NCT ID:
NCT00518739
Start Date:
February 2007
Completion Date:
December 2008
Related Keywords:
- Advanced Cancer
- Neoplasms