Trial of eRapa in Prostate Cancer Patients

• Status: Completed
• Trial end date: 2019-12-02
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rapamycin Holdings Inc.; Rapamycin Holdings, Inc. dba Emtora Biosciences
• Collaborator: Cancer Insight, LLC
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

-

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

Exclusion Criteria:

• 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