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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg,1mg/kg,1.5mg/kg and 2mg/kg
paclitaxel 80mg/m2 as a \> 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks;
topotecan 4 mg/m2 as a \>30 minute IV infusion on days 1, 8, and 15 every 4 weeks ;
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe first affiliated hospital,sun yat-sen university
Guangzhou, Guangdong, China
RECRUITINGthe Affiliated Cancer Hospital of Harbin Medical University
Harbin, Hei Longjiang, China
SUSPENDEDHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGWuhan Union Hospital
Wuhan, Hunan, China
RECRUITINGMaximum Tolerated Dose (MTD)
Time frame: 3 years
The ratio of adverse of event
Time frame: 3 years
Maximum Plasma Concentration [Cmax]
Maximum Plasma Concentration \[Cmax\]
Time frame: 3 years
Area Under the Curve [AUC],
Area Under the Curve \[AUC\]
Time frame: 3 years
Tmax
Tmax for Cmax of sevacizumab
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Progression Free Survival (PFS)
Time frame: 3 years
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