Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression

Inclusion Criteria

• •1. Histologically confirmed diagnosis of endometrial carcinoma.
• •2. Radiographic evidence of disease progression according to modified RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for recurrent metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment option exists.
• •3. Measureable disease meeting the following criteria:
• •* At least 1 lesion of greater than 1.0 cm in the longest diameter for a non-lymph node or greater than 1.5 cm in the short-axis diameter for a lymph node which is serially measureable according to modified RECIST 1.1 using computerized tomography / magnetic resonance imaging.
• •* Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency ablation must show evidence of progressive disease based on modified RECIST 1.1 to be deemed a target lesion.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
• •5. Adequate controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
• •6. Adequate renal function defined as calculated creatinine clearance greater than 30 mL/min per the Cockcroft and Gault formula.
• •7. Adequate bone marrow, blood coagulation, and liver functions, as defined in the study protocol.
• •8. Negative serum or urine pregnancy test for women of reproductive potential.