Clinical Trial Details
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NCT01473095 : Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Men or women ?18 years old

2. 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.

3. Evaluable or measurable disease

4. Life expectancy greater than three months

5. ECOG performance status ?2

6. Hemoglobin (Hgb) ?9.5 g/dl

7. Absolute neutrophil count (ANC) ?1.5 x 10^9/L

8. Platelet count ?75 x 10^9/L

9. Total bilirubin ?1.5 × upper limit of normal (ULN)

10. Aspartate transaminase (AST) and alanine transaminase (ALT) ?3 × ULN

11. 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

12. Agree to use double-barrier contraceptive measures or avoid intercourse during the
study and for 90 days after the last dose of study drug

Exclusion Criteria:

1. 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.

2. Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb

3. Malabsorption syndrome

4. Known brain metastases not radiographically stable for ?3 months or leptomeningeal

5. 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

6. 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)

7. Major surgery within four weeks of the first dose of ARQ 092

8. Previous treatment with AKT inhibitors

9. Concurrent severe uncontrolled illness not related to cancer

10. Ongoing or active known infection, including human immunodeficiency virus (HIV)
infection or bleeding

11. Psychiatric illness/substance abuse/social situation that would limit compliance with
study requirements.

12. Blood transfusion within 5 days prior to blood draw being used to confirm eligibility

13. Pregnant or breastfeeding

14. 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.
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