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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726294
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
NatureWise Biotech & Medicals Corporation

Brief Summary:
NBM-BMX is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by NatureWise. NBM-BMX is a histone deacetylase (HDAC) inhibitor and has been shown to be particularly active against HDAC8. The objectives of this study are to determine the safety profile of NBM-BMX, including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and to determine the Recommended Phase 2 Dose (RP2D).

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Drug: NBM-BMX softgel capsules Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Efficacy of NBM-BMX in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: NBM-BMX Drug: NBM-BMX softgel capsules
Patients will initially receive NBM-BMX orally once a day at 100 mg per day.




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) of NBM-BMX [Safety and Tolerability] [ Time Frame: up to 28 days ]
    Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

  2. Maximum tolerated dose (MTD) of NBM-BMX [Safety and Tolerability] [ Time Frame: up to 28 days ]
    The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.


Secondary Outcome Measures :
  1. Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) [Efficacy] [ Time Frame: at least 8 weeks ]
  2. AUC(0-last) of NBM-BMX [Pharmacokinetics] [ Time Frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days) ]
    AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration

  3. Cmax of NBM-BMX [Pharmacokinetics] [ Time Frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days) ]
    Cmax: maximum plasma concentration

  4. Tmax of NBM-BMX [Pharmacokinetics] [ Time Frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days) ]
    Tmax: time to maximum plasma concentration

  5. T(1/2) of NBM-BMX [Pharmacokinetics] [ Time Frame: Day 1 and 15 for Cycle 1 only (each cycle is 28 days) ]
    T(1/2): terminal elimination half-life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 18 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 or other grade 2 toxicity with prior approval of the Medical Monitor.
  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 ≤1.5 x ULN or creatinine clearance of ≥ 60 mL/min
  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 sponsor, 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., antiarrhythmic 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 antiretroviral therapy. Subjects with known HIV infection and on a stable dose of HIV suppressive medication may be eligible if considered to be at low risk for AIDS-related outcomes following discussion with the medical monitor.
  12. Known hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
  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 sponsor, excess risk associated with study participation or study drug administration, which would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726294


Contacts
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Contact: Jennifer Schulz 858-642-0386 ext 202 jschulz@sciquus.com

Locations
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United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78240
Contact: Anthony W. Tolcher, M.D.    210-595-5670    atolcher@nextsat.com   
Principal Investigator: Anthony W. Tolcher, M.D.         
Sponsors and Collaborators
NatureWise Biotech & Medicals Corporation
Investigators
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Principal Investigator: Anthony W. Tolcher, M.D. NEXT Oncology

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Responsible Party: NatureWise Biotech & Medicals Corporation
ClinicalTrials.gov Identifier: NCT03726294     History of Changes
Other Study ID Numbers: NBM-BMX-001
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms