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A Phase 1b/2, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy 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
Details
| Lead sponsor | Tyme, Inc |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2016-06 |
| Completion | 2019-05-30 |
Conditions
- Prostate Cancer
- Rising Prostate Specific Antigen (PSA)
Interventions
- SM88 (Cohort 1)
- SM88 (Cohort 2)
Primary outcomes
- The dose limiting toxicity (DLT), and maximum tolerated dose (MTD) or minimum effective optimum dose of SM88, when 2 dose levels of SM88 are evaluated. — Six months
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.
Countries
United States