A Single Patient Compassionate Use of MBM-02 (Tempol) for NCT04337099

Clinical Trial Details — Status: Available

Administrative data
NCT number	NCT04337099
Other study ID #	MBI-11-01
Secondary ID
Status	Available
Phase
First received
Last updated

Study information
Verified date	May 2021
Source	Matrix Biomed, Inc.
Contact	Benji Crane
Phone	16264376506
Email	bjcrane[@]matrixbiomed.com
Is FDA regulated	No
Health authority
Study type	Expanded Access

Clinical Trial Summary

A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg.

Description:

Localized therapy for prostate cancer is often curative; however, 20% to 30% of patients experience a recurrence. Biochemical recurrence (BCR) occurs in an estimated 50,000 men/year in the U.S and is marked by a rising prostate specific antigen (PSA) after definitive radical prostatectomy and/or radiation therapy for localized disease. Continuous androgen deprivation therapy (ADT), in which serum testosterone is decreased to a castrate level (less than 50 ng/dL) is a standard treatment in BCR. ADT is associated with significant short term and long term toxicities, including declining quality of life on treatment and increased risk of osteoporosis, diabetes, and cardiovascular disease. MBM-02 is being tested as a novel non-hormonal agent with improved biologic activity and better tolerability for use in biochemically recurrent prostate cancer.

Recruitment information / eligibility
Status	Available
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	Male
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Biochemical Recurrent Prostate Cancer Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MBM-02 (Tempol)
Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.

Locations
Country	Name	City	State
United States	Prostate Oncology Specialists	Marina Del Rey	California

Sponsors *(1)*
Lead Sponsor	Collaborator
Matrix Biomed, Inc.

Country where clinical trial is conducted

United States,

See also
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Recruiting	`NCT03101176` - Multiparametric Ultrasound Imaging in Prostate Cancer	N/A
Completed	`NCT03290417` - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer	N/A
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Recruiting	`NCT03679819` - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed	`NCT03554317` - COMbination of Bipolar Androgen Therapy and Nivolumab	Phase 2
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External Links

Matrix Biomed, Inc. Compassionate Use

A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer

Clinical Trial Details — Status: Available

Administrative data

Study information