Study on the Safety and Effectiveness of NBM-BMX for Treating Metastatic Uveal Melanoma

Program Overview

The purpose of this study is to determine the best dose of NBM-BMX, an investigational drug, for people with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body. The study will help doctors learn about the side effects of NBM-BMX, how the drug is processed in the body, and whether it may slow down or shrink tumors. Participants will take NBM-BMX as a capsule by mouth twice daily on an empty stomach with at least six ounces (180 mL) of water. No food or drink (other than water) should be consumed for at least two hours after each dose. Participants will visit the clinic about once every week or two for exams and blood tests while taking NBM-BMX. After stopping treatment, a follow-up visit will occur about 30 days later. Treatment may continue as long as the cancer does not get worse and side effects remain manageable.

Description

Participants in this study will take NBM-BMX capsules twice a day, about 12 hours apart, for 28 days in a row. This cycle will start on Day 1 of the study. The treatment will continue until the cancer progresses, side effects become too severe, or the participant decides to stop. If the cancer's progression is unclear but the participant seems to be benefiting, treatment may continue with close monitoring.

The capsules must be taken on an empty stomach with at least six ounces of water. Participants should not eat for at least one hour before and two hours after taking the medication. Other oral medications should be taken at least one hour before or two hours after NBM-BMX, unless approved by the study doctor.

Participants should avoid acid-reducing medications like PPIs or H2 blockers, as they may affect how the drug is absorbed. Local antacids can be taken at least two hours before or after the medication if needed.

Participants will receive enough medication for daily use until their next visit, along with instructions on how many capsules to take in the morning and evening. The medication should be stored in its original container at room temperature, away from heat and moisture. Participants should not consume the desiccant in the bottle.

Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use two forms of contraception. If pregnancy is suspected, the medication must be stopped immediately.

Participants will keep a diary to record each dose, any missed doses, and any side effects. Research staff will review the diary and collect unused medication at each visit. If a dose is missed, participants should not try to make it up and should continue with the next scheduled dose.

Screening tests will determine eligibility for the study. Participants must provide written consent before any study-specific procedures.

Safety will be monitored through regular check-ups, including vital signs, physical exams, and lab tests. Tumor response will be assessed every eight weeks.

An Expanded Access program is available for eligible patients. For more information, contact expandedaccess@novelwisepharma.com or visit www.novelwiseoncology.com/expanded-access.

Eligibility Criteria

Locations