The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo. This study is an extension study of the protocol GCT1184-02 (NCT06619236).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Intravenous (IV) infusion
IV infusion
IV infusion
IV infusion
IV infusion
The First Hospital of Jilin University
Changchun, China
RECRUITINGHunan Cancer Hospital
Changsha, China
RECRUITINGWest China Second University Hospital, Sichuan University
Chengdu, China
RECRUITINGChongqing University Cancer Hospital - Chongqing Cancer Hospital
Chongqing, China
RECRUITINGSun Yat-Sen Memorial Hospital
Guangzhou, China
RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, China
RECRUITINGShandong First Medical University Affiliated Tumor Hospital
Jinan, China
RECRUITINGNanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
Nanjing, China
RECRUITING...and 7 more locations
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.
Time frame: Up to approximately 16 months
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause.
Time frame: Up to approximately 25 months
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.
Time frame: Up to approximately 25 months
PFS as Determined by BICR
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 RECIST version 1.1 as determined by BICR.
Time frame: Up to approximately 16 months
ORR as Determined by BICR
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Time frame: Up to approximately 25 months
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 and by blinded independent central review (BICR).
Time frame: Up to approximately 25 months
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.
Time frame: Up to approximately 25 months
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.
Time frame: Up to approximately 25 months
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.
Time frame: Baseline, up to approximately 25 months
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.
Time frame: Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 25 months
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