drugset / Trial / NCT03304210
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Phase 1
Completed
20 enrolled
University Hospital, Ghent
Candiolo Cancer Institute - IRCCS · collabCentre Hospitalier Universitaire Vaudois · collabHopital Lariboisière · collabKom Op Tegen Kanker · collabUniversity Ghent · collabUniversity Women's Hospital Tübingen · collab
RandomizedSingle-groupDouble-blindTreatment
Summary
The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Timeline
- Start
- 2017-09-16
- Primary completion
- 2020-05-06
- Completion
- 2020-05-06
Publications
- Background Van De Sande L, Graversen M, Hubner M, Pocard M, Reymond M, Vaira M, Cosyns S, Willaert W, Ceelen W. Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane) for peritoneal carcinomatosis - a phase I first-in-human study. Pleura Peritoneum. 2018 Jun 8;3(2):20180112. doi: 10.1515/pp-2018-0112. eCollection 2018 Jun 1.
- Results Ceelen W, Sandra L, de Sande LV, Graversen M, Mortensen MB, Vermeulen A, Gasthuys E, Reynders D, Cosyns S, Hoorens A, Willaert W. Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. EBioMedicine. 2022 Aug;82:104151. doi: 10.1016/j.ebiom.2022.104151. Epub 2022 Jul 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 35 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 70 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 112.5 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 140 mg/m2 | — |