What stage is the INNOVATE trial?
The INNOVATE trial for patients with ovarian cancer is a Pilot trial that builds on experience from comprehensive preclinical experiments and clinical studies not directly done for the medical condition under investigation. Because the NovoTTF-100L(O) System is a device and not a drug, it does not follow the traditional Phase I, Phase II, Phase III process that an investigational new drug would follow. This Pivotal Trial is similar in structure and purpose to a drug Phase II trial.
How can I take part in the INNOVATE trial?
Do patients pay to participate in the INNOVATE trial?
No. The trial sponsor will provide the NovoTTF-100L(O) System and all supporting accessories free of charge. See [THE INNOVATE TRIAL] for more information.
What are the expected side effects of TTFields?
The use of the NovoTTF-100L(O) System is not expected to have systemic side effects, based on our clinical data to date for various indications. Patients have experienced skin irritation beneath the transducer arrays. For more information, see [SCIENTIFIC AND CLINICAL EXPERIENCE].
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the skin underneath them.
Please consult with a study physician at one of the centers participating in the trial for additional information about potential side effects from using the NovoTTF-100L(O) and the other treatments in the INNOVATE clinical trial.
Do I need to carry the device all the time?
Will the use of TTFields pose any risk to family members or other people?
How will the device affect my social life?
If I enroll in the INNOVATE trial, will I receive TTFields for my illness?
The INNOVATE study is currently enrolling patients who are amenable to receive paclitaxel (brand name: taxol) for the treatment of their ovarian cancer.