Trial of eRapa in Prostate Cancer Patients

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.

Key facts

Study ID

NCT03618355

Run by

Rapamycin Holdings, Inc. dba Emtora Biosciences

People needed

15

Starts

2018-08-28

Expected to finish

2019-12-02

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• The patient must:
• Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
• Be able to give informed consent
• Be age 18 or older

You may not qualify if…

• Prostate cancer with a Gleason score >7
• Unable to give informed consent
• Age < 18
• Immunosuppressed state (e.g., HIV, use of chronic steroids)
• Active, uncontrolled infections
• On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
• On agents known to alter rapamycin metabolism significantly (Appendix H)
• Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
• Individuals with a reported history of liver disease (e.g., cirrhosis)
• Individuals who are not a good candidate for active surveillance in their treating physician's opinion
• Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
• Uncontrolled hypertension.
• Individuals that have abnormal screening vital organ function prior to enrollment
• Liver Function Test
• Bilirubin >2.0
• Alkaline phosphatase >5x upper limit of normal (ULN)
• ALT/AST >2x ULN
• Complete Blood Count:
• WBC elevated above the normal standard per the testing laboratory
• Hgb/Hct below the normal standards of the testing lab
• Platelets below the normal standards of the testing lab
• Total Cholesterol >240 mg/dL
• Triglycerides > 200 mg/dL
• Serum creatinine >2 and BUN >30
• Urinary protein: proteinuria >1+ on urinalysis or >1 gm/24hr

Where it is running

• UT Health San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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