A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • B013
  • Paclitaxel
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator