CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Rapamycin 3mg +2 moredrug
Likely dose
Rapamycin 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00311623
NCT00311623Phase 2Completed
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A Pharmacodynamic Study of Pre-Prostatectomy Rapamycin in Men With Advanced Localized Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Apr 6, 2006·Updated Feb 22, 2019

In Brief

A Phase 2 clinical trial evaluating Rapamycin 3mg, Rapamycin 6mg, and 1 other intervention for Prostate Cancer. Completed, enrolled 32 participants across 3 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it works before surgery in treating patients with advanced localized prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2006
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2008
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.2 years ago

Interventions

Rapamycin 3mgdrug

Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).

Rapamycin 6mgdrug

Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).

Radical prostatectomyprocedure

Radical prostatectomy performed on Day 15