Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Pancreas CancerMetastatic Pancreatic CancerPancreatic AdenocarcinomaMetastatic Adenocarcinoma
Interventions
COMBINATION_PRODUCT

Modified GCN+TTF treatment

The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.

Trial Locations (1)

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

NovoCure Ltd.

INDUSTRY

lead

Mayo Clinic

OTHER

NCT04605913 - Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC | Biotech Hunter | Biotech Hunter