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To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .
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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 less than 2.
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.
Adequate renal function defined as calculated creatinine clearance greater than 30 mL/min per the Cockcroft and Gault formula.
Adequate bone marrow, blood coagulation, and liver functions, as defined in the study protocol.
Negative serum or urine pregnancy test for women of reproductive potential.
Exclusion criteria
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133 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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