Clinical trial · Interventional
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
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.
NCT06434610CI-TRIAL-00110447recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-resistant Recurrent Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B013 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B013
- interventionNames
- Drug: B013
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Paclitaxel
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Approximately 2 years
- description
- From the date of randomization to the date of progression disease or death , whichever occurred first.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.