Spots Global Cancer Trial Database for A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
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Trial Identification
Brief Title: A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
Official Title: A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.
Study ID: NCT00516373
Interventions
Study Description
Brief Summary: To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Brussels, , Belgium
Research Site, Amsterdam, , Netherlands
Research Site, Szczecin, , Poland
Research Site, Edinburgh, , United Kingdom
Research Site, London, , United Kingdom
Contact Details
Name: Jane Robertson, BSc, MBCHB, MD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Dr. Johann De Bono, PhD MRCP FRCR
Affiliation: Royal Marsden Hospital Trust, London, UK
Role: PRINCIPAL_INVESTIGATOR
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