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This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent Ovarian Cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent Ovarian Cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevacizumab +Chemotherapy Combined chemotherapy drug including | Experimental | Investigators selected single-agent chemotherapy on an individual patient basis from the following options, with appropriate premedication according to local standards: paclitaxel 80mg/m2 intravenously (IV)on days 1, 8, 15, and 22 every 4 weeks; or topotecan 4 mg/m2 IV on days 1, 8, and 15 every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevacizumab | Drug | Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg,1mg/kg,1.5mg/kg and 2mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 3 years | |
| The ratio of adverse of event | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Maximum Plasma Concentration [Cmax] | 3 years |
| Area Under the Curve [AUC], | Area Under the Curve [AUC] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Paclitaxel | Drug | paclitaxel 80mg/m2 as a > 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks; |
|
| Topotecan | Drug | topotecan 4 mg/m2 as a >30 minute IV infusion on days 1, 8, and 15 every 4 weeks ; |
|
| 3 years |
| Tmax | Tmax for Cmax of sevacizumab | 3 years |
| Objective Response Rate (ORR) | 3 years |
| Disease Control Rate (DCR) | 3 years |
| Overall Survival (OS) | 3 years |
| Progression Free Survival (PFS) | 3 years |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
|
| The first affiliated hospital,sun yat-sen university | Recruiting | Guangzhou | Guangdong | China |
|
| the Affiliated Cancer Hospital of Harbin Medical University | Suspended | Harbin | Hei Longjiang | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
|
| Wuhan Union Hospital | Recruiting | Wuhan | Hunan | China |
|
| ID | Term |
|---|---|
| D010051 | Ovarian 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 |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| 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 |
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