This phase 3 study will be conducted in different countries all over the world. The purpose of this 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
530
Intravenous (IV) infusion
IV infusion
IV infusion
IV infusion
IV infusion
Alaska Women's Cancer Care
Anchorage, Alaska, United States
RECRUITINGArizona Center for Cancer Care (ACCC) - Biltmore
Scottsdale, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center - Research and Administration at Main Campus
Tucson, Arizona, United States
RECRUITINGProvidence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Burbank, California, United States
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 2 years
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 3 years
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 3 years
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 3 years
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 3 years
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 3 years
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 3 years
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 3 years
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 3 years
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 3 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Change from Baseline in Electrocardiogram (ECG) Findings to Assess Changes in QTc Associated with Rina-S by Holter Monitor
Time frame: Baseline through Cycle 3 (Cycle length=21 days)
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University of California San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUSCF Mission Bay
San Francisco, California, United States
RECRUITINGKaiser Permanente - Vallejo Medical Center
Vallejo, California, United States
RECRUITINGUCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGYale School of Medicine
New Haven, Connecticut, United States
RECRUITING...and 165 more locations