This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Lafayette, Indiana, United States
Unnamed facility
San Antonio, Texas, United States
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092
Time frame: During the first 29 days of treatment for each dose level
Assess pharmacodynamic activity
Time frame: During the first 29 days of treatment
Determine preliminary evidence of activity as defined by RECIST v 1.1
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Determine recommended Phase 2 dose
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
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