Recruiting NCT06434610
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B013, Paclitaxel, Placebo.
- Who it may be relevant to
- Registry conditions: Platinum-resistant Recurrent Ovarian Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.
Overview
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Interventions
- Drug B013
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. - Drug Paclitaxel
Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle. - Drug Placebo
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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Approximately 2 years]
Secondary outcome measures (5)
- Objective response rate (ORR) [Time frame: Approximately 2 years]
- Disease control rate (DCR) [Time frame: Approximately 2 years]
- Duration of remission (DOR) [Time frame: Approximately 5 years]
- Overall Survival (OS) [Time frame: Approximately 2 years]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 5 years]
Eligibility criteria
Inclusion criteria
- Subjects who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
- ECOG performance status of 0 or 1；
- Expected survival > 12 weeks;
- The subject has at least one measurable lesion;
- Normal function of major organs;
- The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion criteria
- Subjects who have received prescribed treatment previously;
- Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- Subjects with known central nervous system metastasis and multiple bone metastasis;
- 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- Subjects with prescribed cardiovascular diseases;
- Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
- Had severe lung disease before randomization;
- Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was > grade 2, and other reversible toxicity was > grade 1;
- Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
- Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
- Subjects who are known to be allergic to any component of B013 or paclitaxel.
- Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
- Female subjects who are pregnant or breastfeeding;
- Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 17 centers
- Beijing Cancer Hospital — Beijing
- The First Affiliated Hospital of Bengbu Medical University — Bengbu
- XiangYa Hospital CentralSouth University — Changsha
- Fujian Cancer Hospital — Fuzhou
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
- Cancer Hospital of Shandong First Medical University — Jinan
- Qilu Hospital of Shandong University — Jinan
- Yunnan Cancer Hospital — Kunming
- … and 9 more centers
Identifiers
NCT: NCT06434610 · SPH-B013-201