A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors

Inclusion Criteria:

- Histologically confirmed solid tumor that is metastatic or unresectable, and for
which standard curative or palliative measures do not exist or are no longer
effective, and there are no known therapies to prolong survival

- Disease that is measurable according to Response Evaluation Criteria in Solid Tumors
(RECIST)

- Adequate organ and marrow function

- Sexually active patients must use medically acceptable methods of contraception
during the course of the study and at least 11 days after the last dose of study
treatment

- Female patients of childbearing potential must have a negative serum pregnancy test
at screening

- No other history of/or ongoing malignancy that would potentially interfere with the
interpretation of the pharmacodynamic or efficacy assays

Exclusion Criteria:

- Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones)
within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal
therapy or kinase inhibitors) before the first dose of study drug

- The patient has not recovered to Grade 10% of baseline values due to investigational or other agents administered more than
28 days prior to study enrollment

- The patient has received another investigational agent within 28 days of the first
dose of study drug

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris,
or cardiac arrhythmia

- The patient is pregnant or breastfeeding

- The patient is known to be positive for the human immunodeficiency virus (HIV)

- Allergy or hypersensitivity to components of the GDC-0973/XL518 formulation