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Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)

NCT02244502 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-09-21

No results posted yet for this study

Summary

The study is a prospective, single arm, non-randomized, open label pilot trial, designed to study the safety, toxicity, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L(O) concomitant with weekly paclitaxel in recurrent ovarian carcinoma patients. 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

  • Ovarian Carcinoma

Interventions

DEVICE

NovoTTF-100L(O)

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

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 over 1 hour infusion will be administered weekly for 8 weeks and then on days 1, 8, 15 of each subsequent 28 day cycle.

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Principal Investigators

  • Cristina Sessa, MD · Ospedale San Giovanni

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Belgium
  • Germany
  • 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 NCT02244502 on ClinicalTrials.gov