Spots Global Cancer Trial Database for Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

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Trial Identification

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

Official Title: A Phase 1b/2, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SM88 in Patients With Prostate Cancer

Study ID: NCT02796898

Conditions

Prostate Cancer

Rising Prostate Specific Antigen (PSA)

Interventions

SM88 (Cohort 1)

SM88 (Cohort 2)

Study Description

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

Detailed Description: This is an open-label, multi-center, dose-escalating, dose-expansion study of SM88 in patients with prostate cancer. This study includes 2 phases, a dose-escalation phase that includes PK evaluation, and a dose-expansion phase. During the first stage, at up to 2 institutions, up to 2 cohorts of 1 to 6 patients each will be enrolled. During the second stage, the dose selected for evaluation from the Phase 1b will be administered for a total of 30 evaluable patients (inclusive of those treated at the same dose during the dose selection phase) for 6 cycles or until unacceptable toxicity, disease progression, or until any of the treatment discontinuation criteria are met.