Ovarian Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.
Interventions
BIOLOGICALOPT-822/OPT-821
Sponsors
OBI Pharma, Inc
Mackay Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis * Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy. OR * Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis) * Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery .
Exclusion criteria
* Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria. * Subjects who are currently receiving any other concomitant anticancer therapy. * Subjects with evidence of extra-abdominal metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Until disease progression or up to 5 years after the enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Disease Recurrence Rate | At 2 years after the enrollment |
Countries
Taiwan
Contacts
Primary ContactFiona Chen
Outcome results
None listed