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

No results posted yet for this study

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

Interventions

DRUG

chiauranib

50mg orally once daily

DRUG

Placebo

50mg orally once daily

DRUG

Paclitaxel

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921527 on ClinicalTrials.gov