Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 in Adults With Advanced Solid Tumors and Lymphomas

Key Inclusion Criteria:

- Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or
lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for
which no standard therapy is available

- Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast
cancer who are candidates for exemestane or fulvestrant

- Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and
peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or
for which no standard therapy is available

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

- Adequate organ function defined as follows:

- Hematologic: Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9.0 g/ dL; Absolute
neutrophil count (ANC) ≥ 1.5 x 10^9/L (without platelet transfusion or any growth
factors within previous 7 days of the hematologic laboratory values obtained at
screening visit). Patients in the Group 3 lymphoma expansion may be enrolled with
an ANC of ≥ 1.0 x 10^9 /L; Platelets ≥ 75 x 10^9 /L.

- Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) ≤ 2.5 x upper
limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); Total or
conjugated bilirubin ≤ 1.5 x ULN

- Renal: Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 ml/min as
calculated by the cockcroft-gault method

- Coagulation: International Normalized Ratio (INR) ≤ 1.2

Key Exclusion Criteria:

- Known brain metastasis or leptomeningeal disease

- Myocardial infarction, symptomatic congestive heart failure (New York Heart
Association Classification > Class II), unstable angina, or serious uncontrolled
cardiac arrhythmia within the last 6 months of study Day 1

- Major surgery, defined as any surgical procedure that involves general anesthesia and
a significant incision (ie, larger than what is required for placement of central
venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of
study drug

- History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia
method) at screening is prolonged (> 450 ms for males and > 470 ms for females).
Individuals who screen-fail due to this criterion are not eligible to be re-screened

- Clinically significant bleeding within 28 days of study Day 1

- Known human immunodeficiency virus (HIV) infection

- HBsAG positive

- Hepatitis C virus (HCV) antibody positive

- No active anticoagulation within 7 days of study Day 1; including acetylsalicylic
acid, low molecular weight heparin, or warfarin.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.