Ovarian Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : MORAb-003
INN of investigational material : farletuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigati
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies Must have measurable disease by CT or MRI scan Must have relapsed radiologically >- 6 and -< 24 months of completion of first-line platinum/taxane chemotherapy Must be a candidate for repeat carboplatin/taxane therapy Neurologic function: neuropathy (sensory and motor) -< CTCAE Grade 1
Exclusion criteria
Exclusion criteria: Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs 24 months from the last platinum therapy Subjects who have received other therapy to treat their ovarian cancer since relapse Known central nervous system (CNS) tumor involvement Evidence of other active invasive malignancy requiring treatment in the past 5 years Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA Previous treatment with MORAb-003 (farletuzumab) Clinical contraindications to use of a taxane
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) based on central, independent radiologic assessments utilizing RECIST criteria Progression-free survival (PFS) | — |
Outcome results
None listed