Trials / Completed
CompletedNCT04908787
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BD0801 | Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg |
| DRUG | Paclitaxel | Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2 |
| DRUG | Placebo | Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg |
| DRUG | Topotecan | Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2 |
| DRUG | doxorubicin liposome | Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2 |
Timeline
- Start date
- 2021-06-11
- Primary completion
- 2023-12-08
- Completion
- 2024-10-11
- First posted
- 2021-06-01
- Last updated
- 2025-09-11
Locations
55 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04908787. Inclusion in this directory is not an endorsement.