CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
PIPAC with Abraxanedrug
Likely dose
PIPAC with Abraxane 140 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03304210
NCT03304210Phase 1Completed
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Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer

University Hospital, Ghent·interventional·Posted Oct 6, 2017·Updated Nov 7, 2023

In Brief

A Phase 1 clinical trial evaluating PIPAC with Abraxane for Peritoneal Carcinomatosis and 10 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeritoneal Carcinomatosis, Ovarian Cancer Stage IIIB, Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, Breast Cancer Stage IIIB, Breast Cancer Stage IIIc, Breast Cancer Stage IV, Stomach Cancer Stage III, Stomach Cancer Stage IV With Metastases, Pancreas Cancer, Stage III, Pancreas Cancer, Stage IV
CountriesBelgium
CollaboratorsKom Op Tegen Kanker, University Ghent, Hopital Lariboisière, University Women's Hospital Tübingen, Candiolo Cancer Institute - IRCCS, Centre Hospitalier Universitaire Vaudois

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 6, 2017
Enrollment StartSep 16, 2017
Primary CompletionMay 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.7 years ago

Interventions

PIPAC with Abraxanedrug

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.