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NCT06014528

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 3 months later.

See at-risk trials from InxMed (Shanghai) Co., Ltd.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 47 words Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion pushed from Dec 24, 2026 to Mar 24, 2027
    • Site details revised
    • Study description expanded, about 2 words
  2. Primary and study completion dates pushed to Dec 24, 2026v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Timeframe: 2 years.

Secondary (6)

Overall survival (OS), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Progression-free survival (PFS) per RECIST 1.1, as assessed by investigator , following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Objective response rate (ORR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Disease control rate (DCR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Duration of response (DoR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Show 1 moreShow less
Safety and tolerability of IN10018 in combination with PLD vs. placebo in combination with PLD.

Arms and interventions

Experimental ArmExperimental

IN10018+PLD

Control ArmPlacebo comparator

Placebo of IN10018+PLD

Drugs: IN10018, Placebo of IN10018, Pegylated Liposomal Doxorubicin

Sites

1 site in 1 country

  • Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical CollegeBeijing, China