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A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Asian Patients With Advanced Cancer

Study Purpose

NBM-BMX is an orally available new chemical entity to inhibit HDAC8 activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. The objectives of this study are to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors (Arm A) or in combination with the standard of care treatment (i.e., concomitant RT/TMZ followed by adjuvant TMZ) in subjects with newly diagnosed glioblastoma (Arm B).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced, non-resectable, and/or metastatic solid tumor refractory to standard of care therapy, or for whom no standard of care therapy is available, or who were not amenable to established forms of treatment. 2. Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 3. Female or male at 20 years of age or older. 4. ECOG performance status 0 to 2. 5. Recovered from prior treatment-related toxicity to at least grade 1 with exception of grade 2 alopecia. 6. Adequate organ function as defined by the following criteria:
  • - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy.
  • - Total serum bilirubin ≤1.5 x ULN (except for subjects with documented Gilbert's syndrome) - Absolute neutrophil count (ANC) ≥ 1500/µL.
  • - Platelets ≥ 90,000/µL.
  • - Hemoglobin ≥ 9.0 g/dL.
  • - Serum creatinine ≤ 2.0 x ULN.
7. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial: 1. Major surgery or radiation therapy within 28 days of starting study treatment. 2. Systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) of starting study treatment. 3. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 4. Current treatment on another clinical trial. 5. Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks. 6. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and medical monitor, the 6-month post-event-free period for a subject with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted. 7. NYHA Class III or IV heart failure and known history of QTc prolongation or Torsade de Pointes. 8. Use of medications known to significantly prolong the QTc interval (e.g., anti-arrhythmic and psychotropic medications). 9. Hypertension that cannot be controlled by medications. 10. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed). 11. Known human immunodeficiency virus (HIV)-positive and is receiving anti-retroviral therapy. 12. Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody). 13. History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy. 14. Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 15. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or medical monitor, excess risk associated with study participation or study drug administration, which would make the subject inappropriate for entry into this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03808870
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NatureWise Biotech & Medicals Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Neoplasm
Arms & Interventions

Arms

Experimental: NBM-BMX

Interventions

Drug: - NBM-BMX softgel capsules

Patients will initially receive NBM-BMX orally once a day at 100 mg per day.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Cheng Kung University Hospital, Tainan, Taiwan

Status

Address

National Cheng Kung University Hospital

Tainan, , 704

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Address

Taipei Veterans General Hospital

Taipei, , 112