A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed soft tissue sarcoma

- Evaluable disease according to RECIST version 1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

- Eligible for doxorubicin therapy

- Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have
resolved to NCI-CTCAE Grade
- Adequate bone marrow, hepatic and renal function

- Patients with stable CNS metastases are eligible

Exclusion Criteria:

- Previous treatment with limiting doses of doxorubicin

- Patients receiving any other investigational or commercial agents or therapies
administered with the intention to treat their malignancy or other ailment days from Day 1 dosing on study treatment

- History of seizure disorders or unstable CNS metastases

- Severe and/or uncontrolled medical conditions or other conditions that could affect
the participation in the study

- Pregnant or breastfeeding women

- HIV positive patients who are currently receiving combination anti-retroviral therapy

- Patients with known coagulopathy, platelet disorder or history of non-drug induced
thrombocytopenia

- Patients receiving oral or parenteral anti-coagulants/anti-platelet agents