WHO ICTRP trial

A phase II, open-label, non-comparative, international, multicentre study to…

EUCTR2006-006459-10-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-006459-10-DE
Public title A phase II, open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 given orally twice daily in patients with advanced BRCA1- or BRCA2-associated ovarian cancer. - ICEBERG
Scientific title A phase II, open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 given orally twice daily in patients with advanced BRCA1- or BRCA2-associated ovarian cancer. - ICEBERG
Primary sponsor KuDOS Pharmaceuticals Ltd. (a member of the AstraZeneca group of companies)
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Spain;Germany;United Kingdom;Sweden
Conditions Advanced ovarian cancer (stage IIIB/IIIC/IV) and confirmed BRCA+ status MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer
Interventions Product Code: KU 0059436 Pharmaceutical Form: Capsule* INN or Proposed INN: Olaparib CAS Number: 763113-22-0 Current Sponsor code: KU-0059436 Other descriptive name…
Registration date Jul 3, 2007
Target size 64
Secondary IDs KU36-58
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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