At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 1 enrolled

Drug / intervention

Mitotanedrug

Likely dose

Mitotane 1.5 gfrom 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/NCT02057237

NCT02057237Phase 1Completed

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A Safety and Feasibility Study of Mitotane in Prostate Cancer

University Health Network, Toronto·interventional·Posted Feb 7, 2014·Updated Dec 17, 2015

In Brief

A Phase 1 clinical trial evaluating Mitotane for Prostate Cancer. Completed, enrolled 1 participant across 1 site.

Detailed Summary

1. The primary objective of this study is to assess the feasibility of treating patients with metastatic castration resistant prostate cancer with mitotane. Secondary objectives are to assess safety and tolerability as well as response rate of therapy 2. To assess the toxicity of Mitotane in men with HRPC 3. To assess the relationship between baseline serum adrenal androgens and their response to Mitotane

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstate Cancer

CountriesCanada

Collaborators--

Timeline

Phase 1CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartSep 2013

First PostedFeb 2014

Primary CompletionApr 2015

Study CompletionOct 2015

TodayJul 2026

First PostedFeb 7, 2014

Enrollment StartSep 1, 2013

Primary CompletionApr 1, 2015

Study CompletionOct 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 12.4 years ago

Interventions

Mitotanedrug

Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily