Status:
UNKNOWN
MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer
Lead Sponsor:
Matrix Biomed, Inc.
Collaborating Sponsors:
Prostate Oncology Specialists
Conditions:
Prostate Cancer Recurrent
Biochemical Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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.
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 the...
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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
- 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.)
Key Trial Info
Start Date :
May 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04876755
Start Date
May 30 2021
End Date
February 1 2023
Last Update
May 6 2021
Active Locations (1)
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1
Prostate Oncology Specialists
Marina del Rey, California, United States, 90292