Malignant NeoplasmPhase 1NCT03726294
A Safety and Pharmacokinetic Study of NBM-BMX Administered Orally to Patients With Advanced Cancer
A Phase 1 study testing NBM-BMX softgel capsules in people with Malignant Neoplasm, run by NatureWise Biotech & Medicals Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- NBM-BMX softgel capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 25 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Female or male at 18 years of age or older.
- ECOG performance status 0 to 2.
- 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.
- Adequate organ function as defined by the following criteria:
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- 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
- 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.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- Major surgery or radiation therapy within 28 days of starting study treatment.
- Systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) of starting study treatment.
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- Current treatment on another clinical trial.
- Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
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- 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.
- NYHA Class III or IV heart failure and known history of QTc prolongation or Torsade de Pointes.
- Use of medications known to significantly prolong the QTc interval (e.g., antiarrhythmic and psychotropic medications).
- Hypertension that cannot be controlled by medications.
- Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- 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.
- Known hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
- History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Malignant Neoplasm
- Being tested
- NBM-BMX softgel capsules
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBM-BMX softgel capsulesDrug
Patients will initially receive NBM-BMX orally once a day at 100 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| NBM-BMX | Experimental | Not described Receives: Drug: NBM-BMX softgel capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) of NBM-BMX [Safety and Tolerability]
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Measured: up to 28 days
Maximum tolerated dose (MTD) of NBM-BMX [Safety and Tolerability]
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.
Measured: up to 28 days
Secondary outcomes (5)
Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) [Efficacy]
Measured: at least 8 weeks
AUC(0-last) of NBM-BMX [Pharmacokinetics]
AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Cmax of NBM-BMX [Pharmacokinetics]
Cmax: maximum plasma concentration
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Tmax of NBM-BMX [Pharmacokinetics]
Tmax: time to maximum plasma concentration
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
T(1/2) of NBM-BMX [Pharmacokinetics]
T(1/2): terminal elimination half-life
Measured: Day 1 and 15 for Cycle 1 only (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start16 Oct 2018
- Primary completion24 Apr 2020
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NatureWise Biotech & Medicals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony W. Tolcher, M.D., Principal investigator, NEXT Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726294
- Sponsor's protocol ID
- NBM-BMX-001
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2018
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03726294
- Acronym / sponsor ID
- NBM-BMX-001
- Conditions
- Malignant Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NatureWise Biotech & Medicals CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBM-BMX | Experimental | Drug: NBM-BMX softgel capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Female or male at 18 years of age or older.
- ECOG performance status 0 to 2.
- 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.
Key exclusion criteria (16 listed)
- Major surgery or radiation therapy within 28 days of starting study treatment.
- Systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) of starting study treatment.
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- Current treatment on another clinical trial.
- Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBM-BMX softgel capsulesPatients will initially receive NBM-BMX orally once a day at 100 mg per day. | Drug | NBM-BMX |
Primary outcome
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
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.
5 secondary outcomes
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
AUC(0-last) of NBM-BMX [Pharmacokinetics]
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Cmax of NBM-BMX [Pharmacokinetics]
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Tmax of NBM-BMX [Pharmacokinetics]
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
T(1/2) of NBM-BMX [Pharmacokinetics]
Time frame: Day 1 and 15 for Cycle 1 only (each cycle is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony W. Tolcher, M.D. principal investigator
NEXT Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBM-BMX softgel capsules in people with Malignant Neoplasm, run by NatureWise Biotech & Medicals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) of NBM-BMX [Safety and Tolerability] (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.