A clinical study of a new drug called E7080 for patients with cancer of the womb that has spread to other parts of the body after having one platinum based chemotherapy. The patients know they are receiving the drug. The study is being carried out in different countries and the safety and effectivenes of E7080 have been studied in other cancer patients.

Conditions: nresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy
MedDRA version: 14.1Level: PTClassification code 10014741Term: Endometrial cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10014734Term: Endometrial cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10014736Term: Endometrial cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10014740Term: Endometrial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-016858-41-BE

Lead Sponsor: Eisai Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 130

Inclusion Criteria

1) Histologically confirmed diagnosis of endometrial carcinoma.
2) Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior systemic, platinum-based hemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist. Patients with disease progression within 1 year following completion of platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment will be eligible without the requirement for further systemic treatment. Patients who have received platinum-based adjuvant or neoadjuvant treatment and have disease progression more than 1 year following treatment must receive 1 additional cytotoxic systemic treatment before being eligible for enrollment in this study (revised per Amendment 02).
3) Measurable disease meeting the following criteria:
- At least 1 lesion of =1.0 cm in the longest diameter for a non-lymph node or =1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). If there is only 1 target lesion, and it is a non-lymph node, it should have a longest diameter of =1.5 cm (revised per Amendment 02).
- Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
4) ECOG performance status >/=2
5) Adequately controlled BP with or without antihypertensive medications defined as BP <150/90mmHg at screening and no change in antihypertensive medications within 1 week prior to Screening Visit.
6) Adequate renal function defined as calculated creatinine clearance >/=30 mL/min per Cockcroft and Gault formula
7) Adequate bone marrow function:
-ANC >/=1000/mm3
-Platelets >/=100,000/mm3
-Hemoglobin >/=9.0 g/dL
8) Adequate blood coagulation function as evidenced by an INR 9) Adequate liver function:
-Bilirubin -ALT and AST 10) Females age >/=18 years at the time of informed consent
11) Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. (revised per Amendment 02)
12) All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) (revised per Amendment 02).
13) Females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout th

Exclusion Criteria

1) Brain or leptomeningeal metastases including stable metastases
2) More than 1 prior systemic chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma or any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. There is no restriction regarding prior hormonal therapy (revised per Amendment 02).
3) Prior systemic anti-tumour therapy within 3 weeks
4) Not fully recovered from prior radiotherapy based on investigator judgment
5) Subjects with >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour urine protein >/=1 g will be ineligible
6) Gastrointestinal malabsorption or any other condition that might affect the absorption of E7080
7) Inability to take oral medication
8) Major surgery within 3 weeks prior to the first dose of study drug
9) Significant cardiovascular impairment: history of congestive heart failure greater than NYHA Class II; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment
10) Prolongation of QTc interval to >480 msec
11) Bleeding disorder or thrombotic disorders requiring anticoagulant therapy such as warfarin or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin LMWH allowed)
12) Active haemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug
13) Known intolerance to the study drug or any of the excipients
14) Any medical of other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
15) Any malignancy (except for endometrial cancer, basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in situ of the cervix) in the past 2 years (revised per Amendments 01 and 02).
16) Previous treatment with an investigational drug withing 30 days prior to the first dose of study drug
17) Females who are pregnant or breastfeeding