RecruitingPhase 2NCT06014528

IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer


Sponsor

InxMed (Shanghai) Co., Ltd.

Enrollment

168 participants

Start Date

Sep 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding IN10018 (an experimental drug) to a standard chemotherapy drug called pegylated liposomal doxorubicin (PLD) improves outcomes for women with platinum-resistant recurrent ovarian cancer — cancer that came back within 6 months of platinum-based chemotherapy. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer - Your cancer progressed during or within 6 months of platinum-based chemotherapy - You have received no more than 3 prior lines of treatment - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your cancer is primary platinum-refractory (progressed during or within 4 weeks of your very first platinum treatment) - You have had more than 3 prior lines of systemic therapy - You have certain serious heart conditions or uncontrolled infections - You are pregnant or breastfeeding 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

DRUGIN10018

100mg QD orally (PO)

DRUGPlacebo of IN10018

100mg QD orally (PO)

DRUGPegylated Liposomal Doxorubicin

40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)


Locations(1)

Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China

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NCT06014528


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