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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by (Responsible Party): | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01111461 |
Purpose
The purpose of this study is to assess the objective response rate of E7080 in subjects with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: E7080 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy |
| Estimated Enrollment: | 133 |
| Study Start Date: | February 2010 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E7080 |
Drug: E7080
E7080 capsules are administered orally once a day in 28 day cycles to patients with advanced endometrial cancer and disease progression following first-line chemotherapy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Histologically confirmed diagnosis of endometrial carcinoma 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
Measureable disease meeting the following criteria:
Eastern Cooperative Oncology Group (ECOG) performance status <2. Adequately controlled blood pressure with or without antihypertensive medications, defined as BP <150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit Adequately renal function defined as calculated creatinine clearance >30 mL/min per the Cockcroft and Gault formula
Adequate bone marrow function:
Adequate liver function:
Exclusion criteria:
Brain or leptomeningeal metastases, including stable metastases More than 1 prior systemic chemotherapy regimen for recurrent metastatic or primary unresectable endometrial carcinoma or any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. No restriction regarding prior adjuvant chemotherapy or hormonal therapy Prior systemic anti-tumor therapy within 3 weeks Not fully recovered from prior radiotherapy based on investigator judgement Subjects with > 1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with > 1 gm will be ineligible Gastrointestinal malabsorption or any other condition that might affect teh absorption of E7080 Inability to take oral medication Major surgery within 3 weeks prior to first dose of study drug Significant cardiovascular impairment: hx of congestive heart failure greater than New York Heart Association Class II; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; cardiac arrhythmia requiring medical treatment Prolongation of QTc interval >480 msec. 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).
Active hemoptysis within 3 weeks prior to the first dose of study drug Known intolerance to the study drug ( or any of the excipients) Any medical or other conditions which, in the opinion of the investigator, would preclude participation in a clinical trial Active malignancy in the past 2 years other than endometrial cancer unless histologic proof is available demonstrating that recurrent disease is a relapse of endometrial carcinoma Previous treatment with an investigational drug within 30 days prior to first dose of study drug Females who are pregnant or breast feeding.
Contacts and Locations| Contact: Eisai Eisai Medical Services | 1-888-422-4743 |
Show 82 Study Locations| Study Director: | Eisai US Medical Services | Eisai Inc. |
More Information
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01111461 History of Changes |
| Other Study ID Numbers: | E7080-G000-204 |
| Study First Received: | April 16, 2010 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced Endometrial Cancer |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Disease Progression Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Disease Attributes Pathologic Processes |