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| Name | Class |
|---|---|
| Shanghai Pharmaceuticals Holding Co., Ltd | INDUSTRY |
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To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B013 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B013 | Drug | B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From the date of randomization to the date of progression disease or death , whichever occurred first. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. | Approximately 2 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu | Contact | 0086-021-64175590 | JJYIN555@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| Paclitaxel | Drug | Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle. |
|
| Placebo | Drug | Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. |
|
DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
| Approximately 2 years |
| Duration of remission (DOR) | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause. | Approximately 5 years |
| Overall Survival (OS) | Determination of the overall survival times of all participants. | Approximately 2 years |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0. | Approximately 5 years |
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | China |
|
| XiangYa Hospital CentralSouth University | Recruiting | Changsha | China |
|
| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | China |
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| Fudan University Shanghai Cancer center | Recruiting | Shanghai | China |
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| The Obstetrics & Gynecology Hospital of Fudan University | Recruiting | Shanghai | China |
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| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| Shananxi Provincial Cancer Hospital | Recruiting | Xi'an | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | China |
|
| Yibin city second people's Hospital | Recruiting | Yibin | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
|
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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