A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BD0801+chemotherapy BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. |
Drug: BD0801
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Drug: Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Drug: Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Drug: doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
|
| Placebo Comparator: Placebo+chemotherapy Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. |
Drug: Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Drug: Placebo
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Drug: Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Drug: doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Overall Survival (OS) [2.5 year]
OS is the time interval from the date of randomization to death from any cause.
- 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
- 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.
- 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
- Quality Of Life (QoL) [2.5 year]
use EORTC-QLQ-OV28 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]
Eligibility Criteria
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:
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non-epithelial tumours
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ovarian tumours with low malignant potential
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previous treatment with >2 chemotherapy regimens
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prior radiotherapy to the pelvis or abdomen within 5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing | China |
Sponsors and Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SIM-63-OC-301