Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04605913

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

Led by Mayo Clinic · Updated on 2026-02-25

40

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

NovoCure Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis
  • Additional metastases allowed except known brain metastasis
  • No prior treatment for stage IV metastatic disease, but prior neoadjuvant or adjuvant therapy allowed with specific conditions
  • Age 18 years or older
  • Adequate blood counts: ANC > 1500 cells/mm3, platelets > 100,000 cells/mm3, hemoglobin > 8 g/dL
  • Liver function within limits: total bilirubin < 1.5x ULN, ALT or AST < 3x ULN; for liver metastases ALT or AST < 6x ULN and bilirubin < 3x ULN
  • Normal renal function or creatinine clearance > 50 mL/min
  • QTc interval ≤ 470 msec for men and ≤ 490 msec for women
  • Estimated life expectancy of at least 3 months
  • ECOG Performance Status of 0 or 1
  • Ability to operate the Novo TTF-100L system
  • Measurable disease by RECIST 1.1
  • Negative pregnancy test within 14 days prior to treatment for women of child-bearing potential
  • Agreement to use effective contraception during and for 28 days after the study
Not Eligible

You will not qualify if you...

  • Prior frontline therapy for metastatic disease
  • Known brain metastasis
  • Cardiac conduction abnormalities requiring pacemaker
  • Presence of cardiac or abdominal pacemakers or stimulators
  • History of congestive heart failure or myocardial infarction with significant cardiac risk
  • Other major co-morbidities deemed exclusionary by investigators
  • Use of drugs with a black box warning for Torsades de Pointes if no alternative available
  • Known allergy or sensitivity to conductive hydrogels
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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