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About
This study is being done to find the best dose of an investigational drug called NBM-BMX 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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
Signed, written IRB-approved informed consent.
Men and women age ≥ 18 years
ECOG Performance status ≤ 2
Have measurable disease based on RECIST 1.1
Histologic or cytologic confirmation of metastatic uveal melanoma
Previous Therapy
Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:
Longest of one of the following:
Two weeks,
5 half-lives for investigational agents,
o For anti-cancer therapies with half-lives > 8 days, a washout period of at least 28 days will be acceptable,
Standard cycle length of standard therapies.
QTcF <= 480 msec
Adequate hematopoietic capacity, as defined by the following:
Adequate hepatic function, as defined by the following:
Adequate renal function, as defined by the following:
Women/men of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of NBM-BMX.
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion criteria
Patients who meet the following criteria will be excluded from study entry:
Patients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.
Primary purpose
Allocation
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Masking
36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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