What stage is the ENGOT-ov50/INNOVATE-3 study?
The ENGOT-ov50/INNOVATE-3 study for patients with recurrent ovarian cancer is a pivotal study that builds on experience from comprehensive preclinical experiments and clinical studies. Because the NovoTTF-100L(O) is a medical 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 study is similar in structure and purpose to a drug Phase III trial.
What are the expected side effects of TTFields?
The use of the NovoTTF-100L(O) device is not expected to have systemic side effects, based on our clinical data to date. Patients have experienced mild to moderate skin irritation beneath the transducer arrays. For more information, see Science of TTFields. When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the skin underneath them.
Do I need to carry the device all the time?
The device and the portable battery weigh about 3 kilograms or 6 pounds altogether and can be carried in a dedicated shoulder bag or backpack when walking around. Patients may not necessarily be physically carrying the device most of the time, but will rather use it while it is continuously placed in one location (e.g. on a desk, a table or on the floor inside the carrying bag). The device was designed to allow the performance of normal daily routines. Patients participating in the study should wear the device as much as possible. Patients can take breaks during their daily use of the device, as long as the average time on TTFields throughout the entire treatment period is kept at 18 hours per day. For more information on lifestyle related questions, please see Living with TTFields.
Will the use of TTFields pose any risk to family members or other people?
The use of the device should not interfere with household or standard personal electrical devices. There is no exposure of TTFields to non-users, such as co-workers and family members.
How will the device affect my social life?
You can use the device while maintaining most of your daily routines. The transducer arrays will be concealed underneath your clothes. The Device Support Specialist (DSS) will offer help and support related to appearance issues if you are using TTFields. For additional information, please see Living with TTFields.
How long do I need to wear the device in the ENGOT-ov50/INNOVATE-3 study?
Patients wear the device throughout the day and night. Patients may remove the device for short breaks to accommodate personal needs, as long as the average time on TTFields throughout the entire treatment period is kept at 18 hours per day. Treatment on the study continues until your study doctor diagnoses progression of the ovarian cancer in the abdomen according to the protocol, or until a serious medical condition requires discontinuation of the treatment. In addition, you may decide to stop the TTFields at any point in time after starting the use of the device. For more information about the study, see the ENGOT-ov50/INNOVATE-3 study.
Do patients pay to participate in the study?
No. The study sponsor will provide the NovoTTF-100L(O) device and all supporting accessories free of charge. See the ENGOT-ov50/INNOVATE-3 study for more information.