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A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

NCT00516373

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein

Interventions: KU-0059436 (AZD2281)(PARP inhibitor)

Countries: Belgium, Netherlands, Poland, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

* Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
Locations (5)
  • Brussels, Belgium
  • Amsterdam, Netherlands
  • Szczecin, Poland
  • Edinburgh, United Kingdom
  • London, United Kingdom