A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

PHASE2TerminatedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

May 31, 2015

Conditions
Metastatic Castrate Resistant Prostate Cancer
Interventions
DRUG

Tasquinimod

A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.

DRUG

Placebo

Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food

Trial Locations (58)

Unknown

AZ Maria Middelares, Ghent

UZ Gent, Ghent

Leuven

Roeselare

Prague

Prague

Brno

Olomouc

Prague

Aalborg

Aarhus

Copenhagen

Herlev

Angers

Bordeaux

Clermont-Ferrand

Dijon

Lille

Besancon, Lyon

Centre Leon Berard, Lyon

Hopital Edouard Herriot, Lyon

Paris

Saint-Herblain

Toulouse

Villejuif

Aachen

Essen

München

Nürtingen

Tübingen

Bajcsy-Zsilinszky Kórház, Budapest

Országos Onkológia Intézet, Budapest

Uzsoki utcai Kórház, Budapest

Genova

Milan

Modena

Pavia

Roma

Rozzano

Torino

Kaunas

Vilnius

Gdansk

Gdynia

Olsztyn

Urology and Urological Oncology Department and Clinic, Wroclaw

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw

Hospital Clinic Vllarroel, Barcelona

Hospital del Mar, Barcelona

Hospital Valle de Hebrón, Barcelona

Elche

Sabadell

Valencia

Leeds

Guy's & St Thomas NHS Foundation, London

The Royal Marsden NHS Trust, London

University College Hospitals London, London

Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY