Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

Completed · Phase 1

Conditions studied: Solid Tumor, Malignant Lymphoma, Tumor

In brief

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.

Key facts

Study ID

NCT01473095

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

120

Starts

2011-11-01

Expected to finish

2017-08-07

Last updated by the study team

2017-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of Type 1 or 2 diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥160 mg/dL at the prestudy visit. If a diabetic cohort is enrolled, only subjects with a medical history of controlled Type 1 or 2 diabetes mellitus will be enrolled in the cohort.
• Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb (HbA1C)
• Malabsorption syndrome
• Known brain metastases not radiographically stable for ≥3 months or leptomeningeal disease
• History of myocardial infarction (MI) or NYHA Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring >6 months of the first dose of ARQ 092 will be permitted); Grade 2 or worse conduction defect (eg right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/MUGA scan
• Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose of ARQ 092 (within 2 weeks for orally administered drugs)
• Major surgery within four weeks of the first dose of ARQ 092
• Previous treatment with AKT inhibitors
• Concurrent severe uncontrolled illness not related to cancer
• Ongoing or active known infection, including human immunodeficiency virus (HIV) infection or bleeding
• Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.
• Blood transfusion within 5 days prior to blood draw being used to confirm eligibility
• Pregnant or breastfeeding
• Previous other malignancy within 2 years prior to the first dose of ARQ 092, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma and superficial bladder tumors curatively treated.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lafayette, Indiana, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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