Ovarian Neoplasms
Conditions
Brief summary
The primary efficacy endpoint for this cohort is pre-IDS unconfirmed ORR, defined as the percentage of participants with unconfirmed CR or PR on study treatment pre-IDS as assessed per RECIST v1.1 by the Investigator.
Detailed description
Incidence of CA-125 progression per GCIG CA-125 response criteria, PFS, defined as the time from the date of treatment randomization to the date of first documentation of PD per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the Investigator, OS, defined as the time from the date of treatment randomization to the date of death by any cause, TFST, defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death, Safety endpoints include frequency and severity of treatment-emergent adverse events, serious adverse events, AESIs, and dose modification (i.e., interruptions and discontinuations)., Change over time in frequency and severity of the items on the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events during neoadjuvant treatment, Change from baseline in Functional Assessment of Cancer Therapy-Item GP5 during neoadjuvant treatment, Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 items (EORTC Item Library 136) pre-IDS, Change from baseline in EORTC Quality of Life Questionnaire for OC gastrointestinal items (EORTC Item Library 137) pre-IDS
Interventions
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
Sponsors
Tesaro Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint for this cohort is pre-IDS unconfirmed ORR, defined as the percentage of participants with unconfirmed CR or PR on study treatment pre-IDS as assessed per RECIST v1.1 by the Investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of CA-125 progression per GCIG CA-125 response criteria, PFS, defined as the time from the date of treatment randomization to the date of first documentation of PD per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the Investigator, OS, defined as the time from the date of treatment randomization to the date of death by any cause, TFST, defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death, Safety endpoints include frequency and severity of treatment-emergent adverse events, serious adverse events, AESIs, and dose modification (i.e., interruptions and discontinuations)., Change over time in frequency and severity of the items on the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events during neoadjuvant treatment, Change from baseline in Functional Assessment of Cancer Therapy-Item GP5 during neoadjuvant treatment, Change from baseline in European Organisation f | — |
Countries
Spain
Outcome results
None listed