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NCT02796898 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Prostate Cancer and Rising Prostate Specific Antigen (PSA), sponsored by Tyme.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
5
Study locations

NCT02796898: Completed Phase 1 study of Prostate Cancer and Rising Prostate Specific Antigen (PSA), sponsored by Tyme.

NCT02796898 is a Phase 1 study of Prostate Cancer and Rising Prostate Specific Antigen (PSA) that has completed, run by Tyme. The registered enrollment target is 23 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02796898, a Phase 1 study of Prostate Cancer and Rising Prostate Specific Antigen (PSA), has completed, sponsored by Tyme.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
5
Study locations

Study Summary

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

Primary Outcome

During 4 days of single dose PK evaluations \[Phase 1b only\], and six 4-week treatment cycles, we will determine if patients in consecutive cohorts experience any dose limiting toxicity to determine MTD, or a complete response with no DLTs observed to determine the optimum dose.

Interventions

  • DRUG SM88 (Cohort 1)
  • DRUG SM88 (Cohort 2)

Study Locations (5)

New York

  • AccuMed Research Associates - Garden City
  • Montefiore Medical Center- Montefiore Medical Park - The Bronx
  • Eastchester Center for Cancer Care - The Bronx

New Jersey

  • AdvanceMed Research - Lawrence

Pennsylvania

  • MidLantic Urology - Bala-Cynwyd

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2016-06
Est. Completion 2019-05-30
Phase Phase 1
Tyme

2 total trials

What the finished NCT02796898 record still lists

NCT02796898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which SM88 (Cohort 1) is the first listed.

NCT02796898 lists 5 locations in 3 states (New York, New Jersey, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT02796898 about?

NCT02796898 is a clinical study titled "Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer". The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer

What is the current status of trial NCT02796898?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2016-06. Estimated completion is 2019-05-30.

What conditions does trial NCT02796898 study?

This clinical trial studies the following conditions: Prostate Cancer, Rising Prostate Specific Antigen (PSA).

What interventions are being tested in trial NCT02796898?

The interventions under investigation include: SM88 (Cohort 1) (DRUG), SM88 (Cohort 2) (DRUG).

Who is sponsoring clinical trial NCT02796898?

This trial is sponsored by Tyme, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02796898 being conducted?

This trial has 5 study locations across New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02796898's enrollment target sits among peer trials

23 640th of 735 higher than 92 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02796898, the US trial registry maintained by the National Library of Medicine. NCT02796898 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.