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This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Treatment group 1:JSKN003 | Experimental | Drug: JSKN003 JSKN003 dose 1 |
|
| Active Comparator: Treatment group 2: Investigator's choice of chemotherapy | Active Comparator | Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JSKN003 | Drug | Experimental drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first | Up to approximately 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of first dose until the date of death from any cause | Up to approximately 22 months |
| Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingying Wu, Doctor | Contact | 8610-87788495 | wulingying@csco.org.cn |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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To evaluate the efficacy and safety of JSKN003 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
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| Doxorubicin |
| Drug |
Active Comparator |
|
| Paclitaxel | Drug | Active Comparator |
|
| Topotecan | Drug | Active Comparator |
|
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
| Up to approximately 22 months |
| Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1 | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first | Up to approximately 22 months |
| Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1 | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) | Up to approximately 22 months |
| PFS evaluated by the Investigator as per RECIST 1.1 | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first | Up to approximately 22 months |
| ORR evaluated by the Investigator as per RECIST 1.1 | ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) | Up to approximately 22 months |
| DoR evaluated by the Investigator as per RECIST 1.1 | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first | Up to approximately 22 months |
| DCR evaluated by the Investigator as per RECIST 1.1 | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) | Up to approximately 22 months |
| CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria | CA-125 Response Rate was assessed according to the GCIG criteria | Up to approximately 22 months |
| Number and Severity of Treatment-emergent Adverse Events (TEAEs) | The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc. | Up to approximately 22 months |
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |