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An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy

Inclusion 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 >1.5 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 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 <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:

- Absolute neutrophil count >1000/mm3 (>1.0 x 103/u/L);

- Platelets >100,000/mm3 (>100 x 109/L);

- Hemoglobin >9.0 g/dL Adequate blood coagulation function as evidenced by an
International Normalized Ratio <1.5

Adequate liver function:

- Bilirubin <1.5 x ULN except for unconjugated hyperbilirubinaemia of Gilbert's
syndrome

- Alkaline Phosphatase, alanine aminotransferase and aspartate aminotransferase < 3 X
ULN (<5 x ULN if subject has liver metastasis) Age > 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 > 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7080-G000-204

NCT ID:

NCT01111461

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Advanced Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma
  • Disease Progression

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Hackensack, New Jersey  07601
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Charleston, South Carolina  
Honolulu, Hawaii  96813