Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
18 Years and older, Male and Female
Summary
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.
Eligibility
- Men or women =18 years old
- Histologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable.
- Evaluable or measurable disease
- Life expectancy greater than three months
- ECOG performance status =2
- Hemoglobin (Hgb) =9.5 g/dl
- Absolute neutrophil count (ANC) =1.5 x 10^9/L
- Platelet count =75 x 10^9/L
- Total bilirubin =1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) =3 × ULN
- Serum creatinine =1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for subjects with creatinine levels >1.5 x ULN
- Agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug
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