Novocure™ Announces a Phase 1b Clinical Trial to Evaluate the Safety of Marizomib and Temozolomide in Combination with Optune® as Adjuvant Therapy in Patients with Glioblastoma
This trial is the first to study Optune in combination with an investigational drug
ST. HELIER, Jersey–(BUSINESS WIRE)–
Marizomib is a novel, brain-penetrant proteasome inhibitor developed by
“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM,” said Principal Investigator Dr.
The primary objective for the Optune portion of the study is to determine the safety of the combination of marizomib and temozolomide with the addition of Optune in patients entering the adjuvant treatment phase. Secondary objectives for the Optune portion of the study include assessing preliminary clinical activity of the combination of Optune, marizomib and temozolomide in patients entering adjuvant therapy, progression-free survival and overall survival. The protocol has been submitted to an institutional review board, and this arm of the trial is expected to open in the third quarter of 2017.
“We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments,” said Dr.
Tumor Treating Fields in combination with temozolomide and marizomib is experimental for the treatment of glioblastoma. Limited by law to investigational use only.
Headquartered in Jersey,
Important Safety Information
Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by
Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.
Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
Marizomib is an investigational, proteasome inhibitor initially developed by
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Ashley Cordova, 212-767-7558