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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma

Brief 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.

Detailed Summary:

PAST PRE CLINICAL AND CLINICAL EXPERIENCE:

The effect of the electric fields generated by the NovoTTF-100L(O) device (Tumor Treating Fields, TTFields, TTF) has demonstrated significant activity in in vitro and in vivo ovarian carcinoma pre-clinical models both as a single modality treatment and in combination with paclitaxel. TTFields has also shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a small scale pilot study, patients with stage IIIB- IV non-small cell lung cancer (NSCLC) who had had tumor progression after at least one line of prior chemotherapy received Pemetrexed together with NovoTTF Therapy applied to the chest and upper abdomen until disease progression. Efficacy endpoints were remarkably high compared to historical data for Pemetrexed alone.

In a large prospective, randomized trial, in recurrent glioblastoma (GBM). The outcome of subjects treated with NovoTTF Therapy was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF Therapy subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF Therapy to best standard of care (BSC) chemotherapy were seen in all secondary endpoints. Recurrent GBM patients treated with the NovoTTF Therapy in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF Therapy subjects as a group when compared to subjects
Sponsor: NovoCure Ltd.

Current Primary Outcome:

  • Adverse Events Severity and Frequency [ Time Frame: 1.5 years ]
  • Number of patients prematurely discontinuing TTFields due to Skin Toxicity [ Time Frame: 1.5 yeras ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival [ Time Frame: 1.5 years ]
  • Overall Survival [ Time Frame: 1.5 years ]
  • 1 Year Survival Rate [ Time Frame: 1.5 years ]
  • Overall Radiological Response Rate and Duration of Response [ Time Frame: 1.5 years ]
  • CA-125 Response Rate and Duration of Response [ Time Frame: 1.5 years ]
  • Patients' compliance with TTFields Therapy [ Time Frame: 1.5 years ]
    Patient compliance will be assessed by evaluating the device log file which will be downloaded every 4 weeks from the NovoTTF-100L(O) System. Compliance will be presented as an hourly average over a 24 hour period during the 4 weeks and as an average percentage of use over the 4 week period.


Original Secondary Outcome: Same as current

Information By: NovoCure Ltd.

Dates:
Date Received: September 15, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: September 20, 2016
Last Verified: July 2016