Ovarian Cancer
Conditions
Brief 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.
Interventions
DRUGBD0801
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
DRUGPaclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
DRUGPlacebo
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
DRUGTopotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Sponsors
Shanghai Xianxiang Medical Technology Co., Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) by blinded independent review committee(BIRC) | 2 year | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by investigator | 2 year | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria |
| Objective Response Rate (ORR) by investigator | 2 year | Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria |
| Disease Control Rate (DCR) by investigator | 2 year | Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria |
| Objective Response Rate (DOR) by investigator | 2 year | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
| ORR by BIRC | 2 year | Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria |
| DCR by BIRC | 2 year | Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by BIRC according to RECIST 1.1 criteria |
| Overall Survival (OS) | 2.5 year | OS is the time interval from the date of randomization to death from any cause. |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | 2.5 year | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| Quality Of Life (QoL) | 2.5 year | use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire |
| Serum drug concentrations of BD0801 | 2 year | Serum drug concentrations of BD0801 will be calculated. |
| rate of immunogenicity positive reaction | 2 year | — |
| duration of immunogenicity positive reaction | 2 year | — |
| DOR by BIRC | 2 year | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
Countries
China
Outcome results
None listed