Trials / Unknown
UnknownNCT03763123
A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
A Phase Ib, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody(Sevacizumab) Injection Plus Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sevacizumab | Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg，1mg/kg，1.5mg/kg and 2mg/kg |
| DRUG | Paclitaxel | paclitaxel 80mg/m2 as a \> 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks; |
| DRUG | Topotecan | topotecan 4 mg/m2 as a \>30 minute IV infusion on days 1, 8, and 15 every 4 weeks ; |
Timeline
- Start date
- 2018-04-24
- Primary completion
- 2019-12-31
- Completion
- 2020-12-31
- First posted
- 2018-12-04
- Last updated
- 2018-12-04
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03763123. Inclusion in this directory is not an endorsement.