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PLX038 in Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
NCT05465941Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2022
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Polymer-based Nanoparticles, Prodrugs/Conditional Activator Small Molecules
- Drugs
- PLX038
- Conditions
- ovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
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Overview
Phase 2, open-label, single-arm trial of PLX038 in ovarian cancer, primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC), sponsored by Mayo Clinic. Primary endpoint: Overall Response Rate at 18 weeks. Started Sep 2022; status: active, not recruiting.
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Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (pegylated SN-38 conjugate PLX038)
Patients receive PLX038 IV over 1 hour on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Who it enrols
Adults with recurrent, platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancer, with measurable disease, ECOG PS 0-2, and adequate organ function. Excludes patients with recent other malignancies, uncontrolled cardiac disease, active CNS disease, or Gilbert's syndrome.
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Endpoints
Primary
Overall Response Rate
Secondary
Progression-Free Survival
Overall Survival
Adverse Events
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