Clinical trialPhase 1Completed

PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer

Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer

NCT03304210 ↗ ClinicalTrials.gov, retrieved 14 November 2026

Outcome: Results posted; no analysis attached
Phase: Phase 1
Status: Completed
Study type: Interventional
Start: 16 September 2017
Ended: 6 May 2020
Enrollment: 20 participants
Sites: 1
Primary outcomes: Maximally Tolerated Dose (MTD) of Abraxane
Sponsor type: Academic / other
Results posted: 7 November 2023
Last update: 7 November 2023

These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.

Results

Primary endpoint: Results posted; no analysis attachedAs posted on ClinicalTrials.gov ↗, registry record of 7 November 2023
DLT/MTD: Maximally Tolerated Dose (MTD) of AbraxaneAbraxane 35 mg/m²: 0 of 2Abraxane 70 mg/m²: 0 of 2Abraxane 90 mg/m²: 0 of 3Abraxane 112.5 mg/m²: 0 of 3Abraxane 140 mg/m²: 0 of 10Values: ParticipantsTime frame: Within 14 weeks of the start of the treatmentNo analysis posted for this outcome (outcome 1)
Participants: Abraxane 35 mg/m²: 2 started, 2 completedAbraxane 70 mg/m²: 2 started, 2 completedAbraxane 90 mg/m²: 3 started, 3 completedAbraxane 112.5 mg/m²: 3 started, 3 completedAbraxane 140 mg/m²: 10 started, 10 completed
Serious adverse events: Abraxane 35 mg/m²: 2 of 2Abraxane 70 mg/m²: 2 of 2Abraxane 90 mg/m²: 2 of 3Abraxane 112.5 mg/m²: 1 of 3Abraxane 140 mg/m²: 6 of 10Participants with at least one serious adverse event, of those at risk, as posted
Reported in: Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. DOI 10.1016/j.ebiom.2022.104151 ↗ Linked as this trial’s results paper. The numbers above are the registry’s, not the paper’s.

6 secondary outcomes

Surgical Morbidity: Abraxane 35 mg/m² 2, n=2; Abraxane 70 mg/m² 2, n=2; Abraxane 90 mg/m² 3, n=3; Abraxane 112.5 mg/m² 3, n=3; Abraxane 140 mg/m² 10, n=10 [participants]
Maximum Plasma Concentration of Abraxane: Abraxane 35 mg/m² 58 (15), n=2; Abraxane 70 mg/m² 138 (42), n=2; Abraxane 90 mg/m² 101 (13), n=3; Abraxane 112.5 mg/m² 157 (49), n=3; Abraxane 140 mg/m² 184 (68), n=10 [mean ng/mL, Standard Deviation]
Area Under The Curve (AUC) of Abraxane: Abraxane 35 mg/m² 585 (93), n=2; Abraxane 70 mg/m² 962 (237), n=2; Abraxane 90 mg/m² 813 (99), n=3; Abraxane 112.5 mg/m² 1658 (465), n=3; Abraxane 140 mg/m² 2002 (569), n=10 [mean h*ng/mL, Standard Deviation]
Histological Response Via Peritoneal Regression Grading Scoring (PRGS): Abraxane 35 mg/m² 0, n=1; Abraxane 70 mg/m² 1, n=2; Abraxane 90 mg/m² 1, n=3; Abraxane 112.5 mg/m² 0, n=3; Abraxane 140 mg/m² 7, n=8 [participants with tumor regression]
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by…: CTCAE grade <=2: Abraxane 35 mg/m² 0/2; Abraxane 70 mg/m² 0/2; Abraxane 90 mg/m² 1/3; Abraxane 112.5 mg/m² 1/3; Abraxane 140 mg/m² 4/10 [Participants] (first of 3 rows)
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Ass…: CTCAE grade <=2: Abraxane 35 mg/m² 0/2; Abraxane 70 mg/m² 1/2; Abraxane 90 mg/m² 1/3; Abraxane 112.5 mg/m² 2/3; Abraxane 140 mg/m² 3/10 [Participants] (first of 3 rows)

Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Over 85% of women with ovarian cancer (OC) will develop a peritoneal recurrence after initial therapy. The prognosis of patients with recurrent disease is poor, with a median survival ranging from 12 to 24 months. Most of these patients ultimately develop platinum resistant disease (PROC). Current systemic therapy results in a very modest improvement of progression free and overall survival. The addition of locoregional, intraperitoneal (IP) therapy may improve disease control in recurrent OC. Recently, pressurized intraperitoneal aerosol therapy (PIPAC) was added to the therapeutic arsenal. This novel technique allows repeated laparoscopy aided aerosol delivery of anticancer drugs to the peritoneal cavity. Abraxane (nab-pac, Celgene) is a novel 130 nm, albumin-bound (nab) nanoparticle formulation of paclitaxel which has noteworthy single-agent activity and a favourable toxicity profile when used systemically in PROC. A recent phase I study showed a significant pharmacokinetic advantage after IP instillation of nab-pac in patients with peritoneal carcinomatosis from ovarian or gastro-intestinal (GI) origin. In phase I of this study, dose escalation will be combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumour tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Maximally Tolerated Dose (MTD) of Abraxane [Within 14 weeks of the start of the treatment]. Count Of Participants, Participants. Abraxane 35 mg/m² (n=2): 0; Abraxane 70 mg/m² (n=2): 0; Abraxane 90 mg/m² (n=3): 0; Abraxane 112.5 mg/m² (n=3): 0; Abraxane 140 mg/m² (n=10): 0.