NCT01284920 is a Phase 1, PHASE2 clinical trial of MDV3100 in Prostate Cancer, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01284920?

NCT01284920 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01284920?

Interventions in NCT01284920: MDV3100.

What condition does NCT01284920 study?

NCT01284920 studies Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC).

Is NCT01284920 still recruiting?

NCT01284920 is currently completed. Last updated 21 November 2024.

Last reviewed 2024-11-21 · How we verify

NCT01284920

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

Completed Phase 1, PHASE2 Last updated 21 November 2024

What this trial tests

Phase 1, PHASE2 trial testing MDV3100 in Prostate Cancer in 47 participants. Completed in 2 July 2014.

Timeline

2 November 2010

Primary endpoint
12 July 2012

2 July 2014

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	2 November 2010
Primary completion	12 July 2012
Estimated completion	2 July 2014
Sites	7 locations across Japan

Drugs / interventions tested

MDV3100 (mdv3100) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Prostate Neoplasms — all drugs for Prostate Neoplasms →
Castration Resistant Prostate Cancer (CRPC) — all drugs for Castration Resistant Prostate Cancer (CRPC) →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

20 and older, male only, with Prostate Cancer or Prostate Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Enzalutamide as a second generation antiandrogen for treatment of advanced prostate cancer.
Semenas J, Dizeyi N, Persson JL, Persson JL. · · 2013 · cited 33× · PMID 24009414 · DOI 10.2147/dddt.s45703
Beyond castration-defining future directions in the hormonal treatment of prostate cancer.
Niraula S, Chi K, Joshua AM. · · 2012 · cited 17× · PMID 22124843 · DOI 10.1007/s12672-011-0096-0
A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer.
Akaza H, Uemura H, Tsukamoto T, Ozono S, et al · · 2016 · cited 8× · PMID 26793974 · DOI 10.1007/s10147-016-0952-6

Verify or expand the search:

Other trials of MDV3100

Trials testing the same drug.

NCT01565928 — Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer · Phase 1 · completed
NCT01911728 — Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates · Phase 1 · completed
NCT00510718 — A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer · Phase 1 · completed
NCT01606982 — Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Can · approved for marketing

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01284920 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 21 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01284920.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing