Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Description

NBM-BMX will be administered orally twice daily (BID) at approximately 12 ± 2-hour intervals for 28 consecutive days per cycle, beginning on Day 1 of Cycle 1. Patients will continue treatment until disease progression, intolerable toxicity likely attributable to NBM-BMX, or voluntary withdrawal from the study. If disease progression is equivocal and, in the investigator’s judgment, the patient appears to be benefiting, treatment may continue with close monitoring and re-evaluation at the next scheduled tumor assessment.

The study drug will be provided in 100 mg dry powder hard gel capsules. All dosing will be performed on an outpatient basis. NBM-BMX must be taken on an empty stomach with at least six ounces (180 mL) of water.

Patients should not eat food for at least 1 hour before and 2 hours after each dose of NBM-BMX. Only water is permitted during this fasting window.

To minimize the risk of altered absorption, other oral medications should be taken at least 1 hour before or 2 hours after NBM-BMX administration, unless otherwise approved by the Investigator.

Due to the pH-dependent solubility of NBM-BMX, acid-reducing agents (such as PPIs or H2 blockers) may reduce drug absorption. Patients must avoid taking these agents during the study. Local antacids may be taken at least 2 hours before or after dosing if clinically indicated.

Compliance with these fasting instructions should be reinforced at each clinic visit and documented in the patient diary and/or source records.

At each study visit, patients will be dispensed enough drug for daily dosing until the next visit, along with specific instructions on the number of capsules to take in the morning and evening. Drug accountability, including the number of capsules and containers dispensed, patient number, and date of dispensing, will be recorded in the Case Report Form. Patients must store the drug in the original container at room temperature (15 to 25°C) in a secure location away from excessive heat or moisture. Participants will be instructed not to remove or consume the desiccant included in each bottle.

Prior to dispensing, all women of childbearing potential must have a negative pregnancy test, be counseled on the teratogenic potential of NBM-BMX, and agree to use two acceptable forms of contraception, including one barrier method. If pregnancy is suspected, dosing must be discontinued immediately. If pregnancy is confirmed by serum test, the patient will be withdrawn from the study and complete the early termination visit. If pregnancy is ruled out, treatment may be resumed.

Patients will be instructed to complete a dosing diary, recording the date and time of each dose, any missed doses, and any symptoms or side effects experienced. Research staff will review the diary, address any concerns, and collect unused medication and empty containers at each study visit. Every effort will be made to retrieve all dispensed containers; if unsuccessful, the reason will be documented. If a patient misses a dose, participants should not attempt to make it up and should resume treatment at the next scheduled time. All missed doses must be documented in the dosing diary.

SCREENING AND PRETREATMENT ASSESSMENTS Screening tests and evaluations will be used to determine the eligibility of each patient for study inclusion. All patients must provide written informed consent before any study-specific procedures and assessments are performed and any exclusionary medications are discontinued for the purposes of establishing eligibility. Screening evaluations will be performed within the 14 days preceding Day 1, unless otherwise specified. Results of tests or examinations performed as standard of care prior to obtaining informed consent and within 14 days prior to study entry may be used rather than repeating required tests.

ASSESSMENTS DURING TREATMENT All visits must occur within ± 3 days from the scheduled date, unless otherwise noted. All assessments will be performed on the day of the specified visit unless a time window is specified. Assessments scheduled on the day of study drug administration (Day 1) of each cycle should be performed prior to study drug administration, unless otherwise noted.

STUDY COMPLETION/EARLY TERMINATION VISIT Patients who discontinue from the study will be asked to return to the clinic within 30 days of the last dose of NBM-BMX for a follow-up visit.

Assessments and Endpoints Safety will be assessed through adverse event monitoring, vital signs, physical examinations, ECGs, and clinical laboratory tests. Pharmacokinetics will be evaluated at predefined time points. Tumor response will be assessed using RECIST 1.1 criteria every 8 weeks during treatment.

Expanded Access Information:

An Expanded Access program for this investigational product (NBM-BMX) is available for eligible patients under FDA regulations.

For more information, please contact expandedaccess@novelwisepharma.com or visit our website at www.novelwiseoncology.com/expanded-access