Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
NCT04921527 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454
Last updated 2024-10-18
Summary
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.
Conditions
- Ovarian Cancer
- Relapsed or Refractory
- Chiauranib
- Paclitaxel
Interventions
- DRUG
-
chiauranib
50mg orally once daily
- DRUG
-
50mg orally once daily
- DRUG
-
at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;
Sponsors & Collaborators
-
Chipscreen Biosciences, Ltd.
lead INDUSTRY
Principal Investigators
-
Xiaohua Wu · Fudan university Shanghai cancer centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-20
- Primary Completion
- 2024-12-31
- Completion
- 2025-07-31
Countries
- China
Study Locations
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