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Prostate Cancer RecurrentPhase 2NCT04876755

MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer

A Phase 2 study testing MBM-02 in people with Prostate Cancer Recurrent and Biochemical Recurrent Prostate Cancer, run by Matrix Biomed, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open label trial to assess the efficacy of MBM-02 (Tempol) as a treatment for patients diagnosed with prostate cancer in biochemical recurrence. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
MBM-02
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
30 May 2021to Feb 2023
Phase
Phase 2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male 18 years or older;
  • Histologically or cytologically confirmed diagnosis of prostate cancer;
  • Patient must have had previous treatment with definitive surgery or radiation therapy, cryoablation, or brachytherapy;
  • Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure. Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
  • Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy:
  • For radical prostatectomy the threshold for this study is PSA ≥ 0.8ng/mL
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  • For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition).
  • PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached;
  • PSA doubling time ≤ 12 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab.
  • ECOG performance status less than or equal to 2;
  • Ability to swallow the study drugs;
  • If a male with a female partner of child bearing potential, adequate methods of contraception must be employed;
  • If male, no sperm donation for 90 days until after the conclusion of the study;
  • Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
  • Be able to participate for the full term of the clinical investigation;
  • Have a Karnofsky performance status of >70;
  • Have a life expectancy ≥ 6 months; and
  • Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
  • Hematology:
  • Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood
  • Hepatic:
  • Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5 x ULN
  • Renal:
  • creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CrCl female = 0.85 x (CrCl male)

Who cannot join

  • Evidence of metastatic disease on imaging studies (CT and/or bone scan);
  • Diagnosis of diabetes mellitus defined as:
  • Fasting blood glucose > 126 mg/dl or,
  • Random blood glucose > 200 mg/dl
  • Hemoglobin A1C > 6.5%
  • Patients with QTc >480 msec
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  • Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy);
  • Treatment within the last 30 days with any investigational drug;
  • Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed);
  • Patient with previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions: Basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for ≥ 2 years;
  • Evidence of a significant medical illness, or a psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study;
  • Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
  • Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
  • Have used an investigational drug within 28 days of the initiation of study treatment;
  • Have a history of a positive blood test for HIV;
  • At the time of screening, have a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study; and
  • Body weight less than 35 kg (77 lbs.)

Trial locations and contacts

1 site in 1 country.

Benji Crane contact

6264376506

bjcrane@matrixbiomed.com

United States1 site

  • Prostate Oncology Specialists

    Marina del Rey, California, 90292

Other trials in United States

About this study

Official title: An Open Label, Dose Comparison Study to Assess the Efficacy of MBM-02 (Tempol) as a Treatment for Patients Diagnosed With Prostate Cancer in Biochemical Recurrence

This is an open label trial to assess the efficacy of MBM-02 (Tempol) as a treatment for patients diagnosed with prostate cancer in biochemical recurrence.

Read the detailed description

Preliminary data shows MBM-02 has anti-prostate cancer activity without hormone suppression or toxicity to non-cancerous cells and organs.

Solid tumors contain hypoxic regions (low oxygen) due to their high rates of cell proliferation and formation of aberrant blood vessels. Intratumoral hypoxia is associated with increased risk of invasion, metastasis, and patient mortality. Cancer cells respond to hypoxia by stabilizing hypoxia-inducible factor 1 (HIF-1) and hypoxia inducible factor 2 (HIF-2). HIF-1 and HIF-2 activate a transcription of genes encoding proteins that mediate major adaptive responses to hypoxia that are critical for cancer cell survival. Without activation of HIF-1 and HIF-2, cancer cells would not survive.

MBM-02 has been shown to inhibit the genes responsible for prostate carcinogenesis, HIF-1 and HIF-2.

This trial is an open label study that will employ a 3+3 escalation design up to 1600 mg/day. Patients will be exposed to study drug for 20 weeks. PSA and scans will be taken at baseline and week 20 for efficacy.

Being tested
MBM-02

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBM-02Drug

    Also called Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl

    MBM-02 is an HIF-1 and HIF-2 inhibitor.

Study groups in NCT04876755
Study groupRoleWhat they receive
Cohort 1ExperimentalCohort 1 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02
Cohort 2ExperimentalCohort 2 patients will administered 1000 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02
Cohort 3ExperimentalCohort 3 patients will administered 1200 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02
Cohort 4ExperimentalCohort 4 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02
Cohort5ExperimentalCohort 5 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02
Cohort 6ExperimentalCohort 6 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Receives: Drug: MBM-02

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Serum PSA

    To determine whether the proportion of patients who achieve a ≥ 50% decline in serum PSA after 16 weeks of protocol therapy.

    Measured: baseline to week 20

Secondary outcomes (2)

  1. PSA progression

    To determine the median time to PSA progression from the start of protocol therapy with MBM-02 among men with biochemically recurrence prostate cancer.

    Measured: baseline to week 20

  2. Percent Change in PSA

    To determine the mean percent change from baseline after 16 weeks of protocol therapy compared with pre-treatment in PSA doubling time. The pre-treatment PSA doubling time will be determined based upon all PSA measurements obtained within 3 months prior to Day 1 of protocol therapy, with a minimum of three PSA measurements spaced at least 14 days apart

    Measured: baseline to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start30 May 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
For the dose comparison phase, five entry dosing regimens will be explored and represented by Cohort 1 through Cohort 5. The first 3 patients (Cohort 1) will begin with a total daily dose (TDD) of 600 mg of MBM-02. The study will employ a 3+3 design with Cohort 5 dose at 1600 mg/day. Cohort 6 will enroll up to 40 patients at 1600 mg/day of MBM02.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876755
Sponsor's protocol ID
MBI-17-01
Status last verified
May 2021
First submitted
3 May 2021
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided
Expanded access
Available

Publications

  • Thomas R, Sharifi N. SOD mimetics: a novel class of androgen receptor inhibitors that suppresses castration-resistant growth of prostate cancer. Mol Cancer Ther. 2012 Jan;11(1):87-97. doi: 10.1158/1535-7163.MCT-11-0540. Epub 2011 Dec 15.

    PubMed 22172488

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MBM-02 in people with Prostate Cancer Recurrent and Biochemical Recurrent Prostate Cancer, run by Matrix Biomed, Inc. 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 24 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benji Crane (6264376506, bjcrane@matrixbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Serum PSA (time frame: baseline to week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04876755, which also lists 1 linked publication.

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 6 May 2021.

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