Platinum-resistant Ovarian Cancer
Conditions
Brief summary
Progression-Free Survival (PFS) PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Detailed description
1. Overall Survival (OS) OS is defined as the time from date of randomization to date of death due to any cause., 2. Objective Response Rate (ORR) ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator., 3. Duration of Response (DOR) DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator., 4. Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline., 5. Time to Second Disease Progression or Death From any Cause (PFS2) PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death., 6. Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level., 7. Time to Deterioration (TTD) in the GHS/Qol Score TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome., 8. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Laboratory Abnormalities, 9. Change From Baseline in Electrocardiogram (ECG) Findings to Assess Changes in QTc Associated with Rina-S by Holter Monitor
Interventions
DRUGPEGFILGRASTIM
DRUGPACLITAXEL
DRUGTOPOTECAN
DRUGDOXORUBICIN
DRUGGEN1184 DP
DRUGGEMCITABINE
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) OS is defined as the time from date of randomization to date of death due to any cause., 2. Objective Response Rate (ORR) ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator., 3. Duration of Response (DOR) DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator., 4. Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline., 5. Time to Second Disease Progression or Death From any Cause (PFS2) PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapie | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Spain
Outcome results
None listed