PIPAC-nabpac
Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
Sponsor study identifier
interventional
20
1 country
1
Study Start
September 16, 2017
Actual (reported)Primary Completion
May 6, 2020
Actual (reported)Study Completion
May 6, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2017
Actual (reported)September 16, 2017
Actual (reported)October 6, 2017
Actual (reported)May 6, 2020
Actual (reported)May 6, 2020
Actual (reported)November 7, 2023
Actual (reported)Maximally Tolerated Dose (MTD) of Abraxane
The MTD was defined as the highest dose of aerosolized Abraxane, administered 3 times using PIPAC, that does not cause unacceptable side effects. Dose limiting toxicity was recorded in a 14 week-window starting from the first PIPAC and defined a priori as any of the following: 1. any Grade 3 or 4 non-hematologic toxicity excluding fatigue and controllable nausea, vomiting, abdominal pain, and diarrhoea; 2. grade 4 thrombocytopenia; 3. grade 4 neutropenia lasting more than 7 days or associated with fever; 4. failure to perform more than one PIPAC due to toxicity; 5. surgical complication Dindo-Clavien grade IIIB or higher. In order to optimize the balance between safety and efficacy, we used a time-to-event continual reassessment model (TITE-CRM), where an initial design was followed until the first DLT occurred. Conservative a priori estimates of DLT were used to calculate the original dose escalation scheme.
Within 14 weeks of the start of the treatment
Surgical Morbidity
6 months after third PIPAC
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UZ Ghent
Ghent, East-Flanders, 9000, Belgium
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.
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.
Wim P Ceelen, MD, PhD, Prof
University Hospital, Ghent
20 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2017
First Posted
October 6, 2017
Study Start
September 16, 2017
Actual (reported)Maximum Plasma Concentration of Abraxane
T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours
Area Under The Curve (AUC) of Abraxane
T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours
Histological Response Via Peritoneal Regression Grading Scoring (PRGS)
T = 0 minutes, before nebulization
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
Contact the study team to confirm eligibility.
Primary Completion
May 6, 2020
Actual (reported)Study Completion
May 6, 2020
Actual (reported)Last Updated
November 7, 2023
Results First Posted
November 7, 2023
Record last verified: 2023-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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