Solid Tumors
Conditions
Keywords
locally advanced or metastatic solid tumors
Brief summary
This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.
Interventions
DRUGMK2206 every other day
Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.
DRUGMK2206 once weekly
Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy * Has adequate organ function * Is ECOG Performance Scale 0-1 * Has a negative urine pregnancy test if patient is female * Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis
Exclusion criteria
* Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment * Is currently participating or has participated in a study with an investigational compound or device within 28 days * Has a primary central nervous system tumor * Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure * Is a known diabetic who is taking insulin or oral antidiabetic therapy * Is pregnant or breastfeeding or planning to become pregnant during the study * Is positive HIV antibody, HBs antigen or HCV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) | Day 1 - Day 28 (Cycle 1) |
Secondary
| Measure | Time frame |
|---|---|
| Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax | Day 1 - Day 28 (Cycle 1) |
Outcome results
None listed