WHO ICTRP trial

Study to evaluate 2 types of treatment as first line treatment (masitinib +…

EUCTR2013-000809-23-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2013-000809-23-ES
Public title Study to evaluate 2 types of treatment as first line treatment (masitinib + docetaxel or placebo + docetaxel ) in the treatment of patients with metastatic Castrate Resistant Prostate Cancer (mCRPC)
Scientific title A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)
Primary sponsor AB Science
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries United States;Philippines;Hong Kong;Slovakia;Morocco;Greece;Spain;Ukraine;Russian Federation;Italy;India;Malaysia;Peru;South Africa;Tunisia;China;Korea, Republic of;Austria;United Kingdom;Czech…
Conditions metastatic Castrate Resistant Prostate Cancer (mCRPC).;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: masitinib 100mg Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Masitinib mesylate CAS Number: 790299-79-5 Current Sponsor code: AB1010 Other descriptive name: MASITINIB Concentration unit: mg…
Registration date Mar 26, 2014
Target size 550
Secondary IDs AB12003
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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