Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorChipscreen Biosciences, Ltd.

About this trial

This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.

Eligibility criteria

Qualifiers

Willingness to sign a written informed consent document .

Female, age ≥18 yrs and ≤70 yrs.

Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.

Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;

Disqualifiers

Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.

Patients received weekly paclitaxel therapy.

Has known allegies to Chiauranib, paclitaxel or any of the excipients.

Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.

Trial design

Treatments tested in this trial

  • chiauranib
  • Placebo
  • Paclitaxel

Treatment groups

454 Participants
are divided into 2 treatment groups

Sponsors and collaborators