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

Locations

17
Beijing Cancer Hospital Beijing China
The First Affiliated Hospital of Bengbu Medical University Bengbu China
XiangYa Hospital CentralSouth University Changsha China
Fujian Cancer Hospital Fuzhou China

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator