Study of E7080 in Subjects With Advanced Endometrial Cancer and Disease Progression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01111461
First received: April 16, 2010
Last updated: June 18, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: February 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (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
Criteria

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:

  • At least 1 lesion of greater than 1.5 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 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.

Eastern Cooperative Oncology Group (ECOG) performance status less than 2. Adequately controlled blood pressure 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 Adequately renal function defined as calculated creatinine clearance greater than 30 mL/min per the Cockcroft and Gault formula

Adequate bone marrow function:

  • Absolute neutrophil count greater than1000/mm3 (greater than 1.0 x 103/u/L);
  • Platelets greater than100,000/mm3 (greater than100 x 109/L);
  • Hemoglobin greater than 9.0 g/dL Adequate blood coagulation function as evidenced by an International Normalized Ratio less than 1.5

Adequate liver function:

  • Bilirubin less than 1.5 x ULN except for unconjugated hyperbilirubinaemia of Gilbert's syndrome
  • Alkaline Phosphatase, alanine aminotransferase and aspartate aminotransferase less than 3 X ULN (greater than 5 x ULN if subject has liver metastasis) Age greater than 18 years at time of informed consent Must have negative serum or urine pregnancy test for women of reproductive potential

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 greater than 1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with greater than 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 greater than 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111461

  Show 79 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai US Medical Services Eisai Inc.
  More Information

No publications provided

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: June 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Advanced Endometrial Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Disease Progression
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014