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

NCT ID: NCT04337099

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Biochemical Recurrent Prostate Cancer

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Matrix Biomed, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Prostate Oncology Specialists

Marina del Rey, California, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Benji Crane

Role: CONTACT

16264376506

Facility Contacts

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Krista Yasuda

Role: primary

Related Links

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http://matrixbiomed.com/compassionate-use/

Matrix Biomed, Inc. Compassionate Use

Other Identifiers

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MBI-11-01

Identifier Type: -

Identifier Source: org_study_id

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