A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Doxorubicin; Liposomal doxorubicin; Paclitaxel; Topotecan

Criteria

Inclusion Criteria:

• female patients, >/=18 years of age;

• epithelial ovarian, fallopian tube or primary peritoneal cancer;

• platinum-resistant disease (disease progression within <6 months of platinum therapy)

• Eastern Cooperative Oncology Group（ECOG）performance status of 0-1

Exclusion Criteria:

• non-epithelial tumours

• ovarian tumours with low malignant potential

• previous treatment with >2 chemotherapy regimens

• prior radiotherapy to the pelvis or abdomen within 5 years