A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response
This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation
strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and
fallopian tubes cancer who achieve a second Complete Response after a platinum-based
chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with
relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma
will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of
12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be
evaluated every 3 months for the first two years, and every 6 months for more 3 years, and
then in an annual-basis until disease progression or death, whichever happens first.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Increase of Progression Free Survival
PFS is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first. An average of 16.5 months is expected.
Oren Smaletz, MD
Recepta Biopharma S.A.
United States: Food and Drug Administration