Platinum-resistant Recurrent Ovarian Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Interventions
DRUGB013
B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
DRUGPaclitaxel
Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
DRUGPlacebo
Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Sponsors
Shanghai Jiaolian Drug Research and Development Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who voluntarily participate in this study and sign informed consent form; 2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence; 3. ECOG performance status of 0 or 1； 4. Expected survival \> 12 weeks; 5. The subject has at least one measurable lesion; 6. Normal function of major organs; 7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion criteria
1. Subjects who have received prescribed treatment previously; 2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent; 3. Subjects with known central nervous system metastasis and multiple bone metastasis; 4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks; 5. Have a history of other malignant tumors within 5 years before signing the informed consent; 6. Subjects with prescribed cardiovascular diseases; 7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization; 8. Had severe lung disease before randomization; 9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1; 10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery; 11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs; 12. Subjects who are known to be allergic to any component of B013 or paclitaxel. 13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders; 14. Female subjects who are pregnant or breastfeeding; 15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Approximately 2 years | From the date of randomization to the date of progression disease or death , whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Approximately 2 years | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. |
| Disease control rate (DCR) | Approximately 2 years | DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease. |
| Duration of remission (DOR) | Approximately 5 years | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause. |
| Overall Survival (OS) | Approximately 2 years | Determination of the overall survival times of all participants. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 5 years | The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0. |
Countries
China
Contacts
CONTACTXiaohua Wu
Outcome results
None listed