Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •5. Significant toxicities resulting from prior therapy must have recovered.
• •6. If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
• •7. If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
• •8. The patient has adequate ability to perform activities of daily living.
• •9. The patient has adequate organ function as assessed by laboratory tests
• •A patient will not be eligible for study participation if any of the following criteria apply:
• •1. The patient weighs more than 264 lbs.
• •2. The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
• •3. The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
• •4. The patient has known brain tumors.
• •5. The patient experienced blood clots within six months prior to study start.
• •6. The patient has a non-healing wound, ulcer or bone fracture.
• •7. The patient received recent thrombolytic or anticoagulant therapy.
• •8. The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
• •9. The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
• •10. The patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (LHRH) agonists.