A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma

Inclusion Criteria:

1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma.
Patients with sarcoma of small round blue cell tumor types are allowed.
Gastrointestinal stromal tumors (GIST) are excluded.

2. Patients must have received at least one prior anticancer regimen for metastatic
disease unless there is no other therapy available and evidence of progressive disease
on study entry. Patients with stable disease will be included if there has been
failure to respond to another drug(s) within the previous 3 months

Exclusion Criteria:

1. Patients with known liver metastases

2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or
participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of
therapy

3. Patients with known brain metastasis

4. Patients with any gastrointestinal dysfunctions that could interfere with the
interpretation of the food effect data

5. Patients with known intolerance to low or high fat meals

6. In the opinion of the investigator, patients who are significantly below their ideal
body weight