A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients

Exclusion Criteria

• •1. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrolment. Male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records)
• •2. Receipt of any chemotherapy for RCC
• •3. Had cardiac angioplasty or stenting event, myocardial infarction or unstable angina within 3 months of study entry
• •4. Persistent QTc \>450 ms for males, or \>470 ms for females, according to Fridericia's correction
• •5. Patients with Grade 3 or greater hyponatremia at screening
• •6. History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification
• •7. History of another malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, and not disease free ≥5 years
• •8. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam
• •9. History of human immunodeficiency virus infection
• •10. Presence of active, uncontrolled infection
• •11. Radiotherapy received within 4 weeks prior to baseline
• •12. Use of any investigational agents within 4 weeks of baseline
• •13. Major surgery within 4 weeks prior to baseline
• •14. Receipt of radiotherapy to \>25 % of bone marrow
• •15. Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 enzymes (Appendix D1), unless approved by the Sponsor
• •16. Uncontrolled intercurrent illness that would jeopardize patient safety, or interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator