Advanced Cancer
Conditions
Brief summary
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.
Interventions
DRUGMK2461
Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of MK2461 | 18 Months |
Secondary
| Measure | Time frame |
|---|---|
| To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics. | 18 Months |
Outcome results
None listed