Neoplasm
Conditions
Brief summary
A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus (MK-8669) in participants with locally advanced or metastatic solid tumors.
Interventions
DRUGRidaforolimus
Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent 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
* Histologically - Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Have Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Does Not Exist * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Adequate Organ Function
Exclusion criteria
* Participant Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration * Any central nervous system Metastasis Which Has Symptoms Or Requires Treatment * Any Primary Central Nervous System Tumor * Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment * A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Participant's Participation, Or Pose An Additional Risk To The Participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Ridaforolimus Dose Limiting Toxicities | Cycle 1 (28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg) | Day 1 |
| Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg) | Day 26 |
| Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg) | Day 1 |
| Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg) | Day 26 |
Outcome results
None listed