An Open-Label, Phase I/II, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
Inclusion Criteria:
- Histologically documented, locally advanced or metastatic solid malignancy that has
progressed or failed to respond to at least one prior regimen and are not candidates
for regimens known to provide clinical benefit
- Phase II: Post-menopausal female patients with locally advanced or metastatic hormone
receptor-positive breast cancer
- Evaluable or measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening
- Life expectancy of >= 12 weeks
- Adequate hematologic and organ function within 14 days prior to initiation of study
treatment
- Documented willingness to use an effective means of contraception for both men and
women while participating in the study
Exclusion Criteria:
- Known and untreated, or active central nervous system (CNS) metastases (progressing
or requiring treatment)
- Grade >=2 peripheral neuropathy
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Patients requiring any daily supplemental oxygen
- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis
- Treatment with chemotherapy <= 3 weeks before study treatment
- Treatment with investigational drug <= 4 weeks before study treatment
- Treatment with biologic therapy <= 3 weeks before study treatment
- Treatment with kinase inhibitors <= 2 weeks before study treatment
- Radiation therapy (other than radiation to bony metastases) as cancer therapy <= 4
weeks before study treatment
- Palliative radiation therapy to bony metastases <= 2 weeks before study treatment
- Major surgery <= 4 weeks before study treatment
- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic
dysfunction, physical examination finding, or clinical laboratory finding giving
reasonable suspicion of a disease or condition that contraindicates the use of an
investigational drug, that may affect the interpretation of the results, or renders
the patients at high risk from treatment complications