RecruitingPhase 3NCT04921527

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

A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer


Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

454 participants

Start Date

Dec 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chiauranib (a targeted therapy) and weekly paclitaxel (a chemotherapy drug) for women with ovarian cancer that has come back and is no longer responding to platinum-based chemotherapy. **You may be eligible if:** - You are a woman aged 18–70 with confirmed ovarian, fallopian tube, or peritoneal cancer - Your cancer is platinum-refractory (progressed during or shortly after platinum therapy) or platinum-resistant (progressed within 6 months of platinum treatment) - You have received no more than 1 prior treatment regimen for recurrent disease - Your cancer is measurable on imaging - Your blood counts and organ function are within acceptable ranges - Your overall health is good (ECOG 0 or 1) **You may NOT be eligible if:** - You have received more than 1 prior treatment for recurrent disease - Your blood counts are too low (severe anemia, low platelets, or low neutrophils) - Your kidney or liver function is significantly impaired - Your cancer has not progressed on imaging during the last treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGchiauranib

50mg orally once daily

DRUGPlacebo

50mg orally once daily

DRUGPaclitaxel

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 ;


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China, China

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NCT04921527


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