Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD0801 | Drug | — | UNRESOLVED |
| doxorubicin liposome | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BD0801+chemotherapy
- description
- BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
- interventionNames
- Drug: BD0801
- Drug: Paclitaxel
- Drug: Topotecan
- Drug: doxorubicin liposome
- type
- PLACEBO_COMPARATOR
- label
- Placebo+chemotherapy
- description
- Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
- interventionNames
- Drug: Paclitaxel
- Drug: Placebo
- Drug: Topotecan
- Drug: doxorubicin liposome
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or \> 1 line of non-platinum systemic therapy prior to platinum resistance. * prior radiotherapy to the pelvis or abdomen
References
Publications (0)
Data not yet available