drugset / Trial / NCT05277766
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
Phase 1
Active not recruiting
45 enrolled
University Hospital, Ghent
Kom Op Tegen Kanker · collabUniversity Ghent · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.
Timeline
- Start
- 2022-11-21
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 30 mg/m2 | Other |
| Subject | Irinotecan | Small molecule | 45 mg/m2 | Other |
| Subject | Irinotecan | Small molecule | 60 mg/m2 | Other |
| Subject | Irinotecan | Small molecule | 75 mg/m2 | Other |
| Subject | Irinotecan | Small molecule | 90 mg/m2 | Other |