A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors

Study start date: March 29, 2013

Key Inclusion Criteria: Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available Part B: Pancreatic Adenocarcinoma Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma Part B: NSCLC Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC Absence of known epidermal growth factor receptor (EGFR) mutation Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion) Part B: Esophagogastric Adenocarcinoma: Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion) Part B: First-Line Colorectal Cancer Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum Radiographically measureable disease No prior cytotoxic chemotherapy to treat their metastatic disease Part B: Second-Line Colorectal Cancer Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum Radiographically measureable disease Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion Part B: Breast Cancer Histologically or cytologically confirmed metastatic breast cancer Radiographically measureable disease Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician HER-2 negative tumor (primary tumor or metastatic lesion) Adequate organ function Key Exclusion Criteria: Pregnant or lactating Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted Note: Other protocol defined Inclusion/Exclusion criteria may apply.