BridgeMD
Tests treatment safety and results for Metastatic Uveal Melanoma
Official title Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT07136181
What this study is testing
What is NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers.?
NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers. is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic uveal melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Patients must meet the following criteria to be eligible for study entry:
- Signed, written IRB-approved informed consent.
- Men and women age ≥ 18 years
- ECOG Performance status ≤ 2
- Have measurable disease based on RECIST 1.1
You likely can't join if
- Patients who meet the following criteria will be excluded from study entry:
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of...
- Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
- History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated...
- Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the...
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a...
See the full eligibility criteria
- \- Patients must meet the following criteria to be eligible for study entry:
- 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
- Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) has elapsed between any major surgery and date of registration, and that wound healing has occurred.
- Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.
- Other Systemic Therapy: There is no limit to the number of prior therapies received for metastatic uveal melanoma. Prior treatment with tebentafusp is required for HLA-A\ 02:01-positive patients unless unavailable or...
- 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:
- Hemoglobin ≥ 9.0 g/dL and not transfusion dependent
- Platelets ≥ 100,000/mm3
- Absolute neutrophil count ≥ 1,500 cells/mm3
- Adequate hepatic function, as defined by the following:
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present
- Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease
- Albumin ≥ 3.0 g/dL
- Adequate renal function, as defined by the following: \- Renal: calculated creatinine clearance \>45 mL/min for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula...
- 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.
- Patients who meet the following criteria will be excluded from study entry:
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration...
- Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
- History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the...
- Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or...
- Difficulty with swallowing oral medications.
- Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
- A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
- Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including...
- Current use or anticipated need for P-gp or BCRP inhibitors during the study period.
- Use of proton pump inhibitors (PPIs), H2-receptor antagonists, or other systemic acid-reducing agents within 7 days prior to Cycle 1 Day 1 or planned use during the study treatment period, unless the patient can be...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Denver, Colorado, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Denver, Colorado, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.