Dosing Information Sample Clauses

Dosing Information. Patients will receive oral KPT-9274 three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28-day cycle. Study treatment will be administered in the clinic and at home as indicated in Table 4. Study treatment dosing will occur in the clinic during Cycle 1 on Days 1, 3, 8, 15, 22, 24, and 26, during Cycle 2 on Days 1, 8, 15, and 22, and during ≥ Cycle 3 on Days 1 and 15. Study treatment dosing will occur at home during Cycle 1 on Days 5, 10, 12, 17, and 19, during Cycle 2 on Days 3, 5, 10, 12, 17, 19, 24, and 26 and during Cycles ≥ 3 on Days 3, 5, 8, 10, 12, 17, 19, 22, 24, and 26. During Part B of the Dose Escalation Phase, patients will receive 500 mg niacin ER co-administered with each dose of KPT-9274. The starting dose of 500 mg niacin ER may be titrated to 2,000 mg of daily dose, per label. The starting dose for KPT-9274 in Part B will be a dose and schedule that cleared DLT assessment during Part A. For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used during both Part A and Part B. A total of ~65 patients with advanced solid malignancies and NHL may be enrolled to further explore safety, tolerability and preliminary evidence of anti-tumor activity of the RP2D of KPT-9274 ± niacin ER. After declaring the RP2D ± niacin ER (see Section 6.2.6), based on the safety and tolerability results of the Dose Escalation Phase, a decision will be made whether expansion (4 groups, ~45 patients total) will be conducted at the RP2D of KPT-9274 single agent or at the RP2D of KPT-9274 + niacin ER. If the 45 patient expansion is conducted at the RP2D of KPT-9274 + niacin ER, an optional expansion with < 20 patients at the RP2D of KPT-9274 single agent may be initiated. Futility analyses based on clinical efficacy will be conducted in a maximum of 10 patients dosed at the RP2D ± niacin ER (see Section 6.2.7 for additional details). Dose escalation will occur according to the Dose Escalation Guidelines provided in Section 6.2.6. Patients with melanoma enrolled in Part C, KPT-9274 + nivolumab, cohort will receive nivolumab (480 mg once per 28 day cycle) according to the current prescribing information.

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.