A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
About this trial
Last updated 3 years ago
Study ID
SIM-63-OC-301
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
18+ Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
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