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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: BD0801
* Drug: Paclitaxel
* Drug: Placebo
* Drug: Topotecan
* Drug: doxorubicin liposome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BD0801+chemotherapy<br>BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. | Drug: BD0801<br>* Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg<br>Drug: Paclitaxel<br>* Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2<br>Drug: Topotecan<br>* Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2<br>Drug: doxorubicin liposome<br>* Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2<br>|
| Placebo Comparator: Placebo+chemotherapy<br>Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. | Drug: Paclitaxel<br>* Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2<br>Drug: Placebo<br>* Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg<br>Drug: Topotecan<br>* Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2<br>Drug: doxorubicin liposome<br>* Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival(PFS) by blinded independent review committee(BIRC) | 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 | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is the time interval from the date of randomization to death from any cause. | 2.5 year | 
| PFS by investigator | 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 | 2 year | 
| Objective Response Rate (ORR) by investigator | Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria | 2 year | 
| Disease Control Rate (DCR) by investigator | 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 | 2 year | 
| Objective Response Rate (DOR) by investigator | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. | 2 year | 
| ORR by BIRC | Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria | 2 year | 
| DCR by BIRC | 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 | 2 year | 
| DOR by BIRC | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. | 2 year | 
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 | 2.5 year | 
| Quality Of Life (QoL) | use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire | 2.5 year | 
| Quality Of Life (QoL) | use EORTC-QLQ-OV28 questionnaire | 2.5 year | 
| Serum drug concentrations of BD0801 | Serum drug concentrations of BD0801 will be calculated. | 2 year | 
| rate of immunogenicity positive reaction |  | 2 year | 
| duration of immunogenicity positive reaction |  | 2 year |