Dosing Information. Study treatment tablets should be taken orally with at least 120 mL (4 ounces) of water. Study treatment can be taken with or without food. In order to avoid contact with skin, tablets must be swallowed whole and should not be crushed. Eligible patients must be able to take oral medication when informed consent is obtained. If a patient is later intubated or unable to take oral medication during treatment, it is permissible to use selinexor suspension prepared as below: A suspension of selinexor and/or placebo can be prepared by the site pharmacy from selinexor tablets, water, and the commercial suspension agent Ora-Blend®. The pharmacy should place one 20 mg active or placebo tablet in a bottle (amber if available) and add 3 mL of water to disintegrate the tablet, then add 9 mL of Orablend® suspending agent. Gentle swirling or inversion of the capped bottle will mix the suspension and suspend selinexor for dosing. The resulting suspension should be dosed within 4 hours. Administer the suspension to the patients using an oral dosing syringe via a nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) feeding tube. Rinse the bottle, syringe and tube with 40 mL to 110 mL of saline and dose the saline rinse to the patient to ensure complete delivery of the selinexor/placebo dose. Handling Precaution: Selinexor tablets are coated for easy handling. Do not break, cut, or crush selinexor tablets because of increased risk of dermatologic toxicity (e.g., rash) from exposure to the active ingredient in the tablets. Handling Precaution: The tablets quickly disintegrate in water (<10 min) without being crushed. Please wear gloves when handling the suspension to prevent unintended exposure to the active ingredient. The site pharmacy should consult the pharmacy manual for full instructions on preparing and handling the suspension and for alternative suspending agents should Ora-Blend® be unavailable.
Dosing Information. Selinexor tablets should be taken orally with at least 120 mL (4 fluid ounces) of water. Selinexor can be taken with or without food. In order to avoid contact with skin, tablets must be swallowed whole and should not be crushed. For additional details on drug formulation, preparation, and administration, please refer to the Pharmacy Manual and the Investigator’s Brochure. Pembrolizumab (Arm B) will be administered at the site, only by authorized site personnel. Trifluridine and tipiracil (Arm C) should be taken with food and should be taken at home unless there is a site visit on the dosing day as appropriate.
