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Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

NCT02796898 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-07-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer

Conditions

Interventions

DRUG

SM88 (Cohort 1)

* Tyrosine Isomers - 230 mg qd * Phenytoin - 50 mg qd. * Methoxsalen - 10 mg qd * Sirolimus - 0.5 mg qd

DRUG

SM88 (Cohort 2)

* Tyrosine Isomers - 460 mg (230 mg bid) * Phenytoin - 50 mg qd * Methoxsalen - 10 mg qd * Sirolimus - 0.5 mg qd

Sponsors & Collaborators

  • Tyme, Inc

    lead INDUSTRY

Principal Investigators

  • Giuseppe Del Priore, MD, MPH · Chief Medical Officer TYME Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-05-30
Completion
2019-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796898 on ClinicalTrials.gov