A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology

Inclusion Criteria:

- Age 18 and older

- Solid tumors refractory to standard therapy

- For the Extension cohorts, patients must have measurable disease by RECIST criteria
and meet the following disease-specific criteria:

- For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland,
patients must not be candidates for curative surgery or radiotherapy.

- For pigmented villo-nodular synovitis (PVNS), patients must have a
histologically confirmed diagnosis of inoperable progressive or relapsing PVNS,
or resectable tumor requesting mutilating surgery, as well as demonstrated
progressive disease in the last 12 months.

- For gastrointestinal stromal tumors (GIST), patients must have failed previous
therapy with imatinib and sunitinib. Patients with known PDGFR mutations are
excluded, but mutation testing is not required for study entry.

- For anaplastic thyroid cancer (ATC), patients must have histologically or
cytologically diagnosed advanced ATC.

- For metastatic solid tumors with documented malignant pleural and/or peritoneal
effusions, patients must not be receiving specific therapy for the effusion or
have an indwelling drain.

- ECOG performance status 0 or 1

- Life expectancy > 3 months

- Adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

- Specific anti-cancer therapy within 3 weeks of study start

- Uncontrolled intercurrent illness

- Refractory nausea or vomiting, or malabsorption

- Mean QTc > 450 msec