CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
sipuleucel-T +1 morebiological
Likely dose
enzalutamide 160 mgfrom 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/NCT01981122
NCT01981122Phase 2Completed
CompareCT.gov

A Randomized, Open-label, Phase 2 Study of Sipuleucel-T With Concurrent Versus Sequential Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

Dendreon·interventional·Posted Nov 11, 2013·Updated Oct 24, 2018

In Brief

A Phase 2 clinical trial evaluating sipuleucel-T and enzalutamide for Metastatic Prostate Cancer. Completed, enrolled 52 participants across 19 sites.

Detailed Summary

This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 11, 2013
Enrollment StartSep 1, 2013
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.6 years ago

Interventions

sipuleucel-Tbiological

Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

enzalutamidedrug

Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.