Lenvatinib in Second Line Endometrial Carcinoma

• Female subjects age ≥18 years at the time of informed consent
• World Health Organization (WHO) Performance Status of 0 or 1
• Patients with histologically confirmed endometrial cancer including serous-papillary and clear cell histologies. Uterine carcinosarcomas are allowed.
• Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist.
• Patients with disease progression following platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment are also eligible.
• Patients may have received prior radiotherapy and / or adjuvant chemotherapy for early high-risk disease
• Patients may not have received prior treatment with anthracyclines
• Blood samples available for retrospective central assessment of Ang-2 level
• Patients may have had prior therapy providing the following conditions are met:
• Surgery and radiation therapy: wash-out period of 14 days and subjects must have recovered adequately from any toxicity and/or complications from radiotherapy and major surgery prior to starting therapy.
• Systemic anti-tumor therapy or any investigational agent: wash-out period of 21 days (or 5 x half-life)
• Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.) except alopecia
• Adequate contraceptive measures
• Signed written informed consent

Exclusion Criteria:

• Inadequate hematologic, renal and hepatic functions
• Abnormal cardiac function