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Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA)

NCT01971281 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-09-13

No results posted yet for this study

Summary

The study is a prospective, double arm, non-randomized, open label pilot trial, designed to study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DEVICE

NovoTTF-100L

Patients will be treated continuously with the NovoTTF-100L. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week rest from treatment. Subsequent cycles will consist of once weekly infusions days 1, 8, 15 every 28 days.

DRUG

nab-Paclitaxel

nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on days 1, 8 and 15 of each 28-day cycle.

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Principal Investigators

  • Rocio Garcia Carbonero, MD · Hospital 12 de Octubre

  • Carmen Guillen, MD · Hospital Ramon Y Cajal

  • Manuel Benavides-Orgaz, MD · Hospital Universitario Carlos Haya

  • Javier Gallego-Plazas, MD · Hospital General Universitario de Elche

  • Fernando Rivera, MD · Hospital Universitario Santander

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971281 on ClinicalTrials.gov