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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20253987 | Other Identifier | Registry ID: ChinaDrugTrials.org.cn |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rina-S | Experimental |
| |
| Investigator's Choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rina-S | Drug | Intravenous (IV) infusion |
|
|
| Measure | Description | 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. | Up to approximately 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of randomization to date of death due to any cause. | 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. |
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Key Inclusion Criteria:
Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Participants may be enrolled regardless of FRα expression level.
Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
Participants must have received prior treatment with the following therapies:
Mirvetuximab soravtansine, if:
Participants must have platinum-resistant disease:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genmab Trial Information | Contact | +4570202728 | clinicaltrials@genmab.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | ||||
| Peking Union Medical College Hospital |
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| Paclitaxel | Drug | IV infusion |
|
| Topotecan | Drug | IV infusion |
|
| Pegylated liposomal doxorubicin (PLD) | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | Up to approximately 25 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 25 months |
| Beijing |
| China |
| Chongqing University Cancer Hospital - Chongqing Cancer Hospital | Chongqing | China |
| Fujian Provincial Cancer Hospital | Fujian | China |
| Sun Yat-Sen Memorial Hospital | Guangdong | China |
| Sun Yat-Sen University Cancer Center | Guangdong | China |
| Harbin Medical University Cancer Hospital | Heilongjiang | China |
| Henan Cancer Hospital | Henan | China |
| Hunan Cancer Hospital | Hunan | China |
| Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School) | Jiangsu | China |
| The First Hospital of Jilin University | Jilin City | China |
| Liaoning Cancer Hospital | Liaoning | China |
| Shandong Cancer Hospital | Shandong | China |
| Fudan University Shanghai Cancer Hospital | Shanghai | China |
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai | China |
| Shanxi Cancer Hospital | Shanxi | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Shanxi | China |
| West China Second University Hospital, Sichuan University | Sichuan | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China |
| Zhejiang Cancer Hospital | Zhejiang | China |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| C506643 | liposomal doxorubicin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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