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.

AstraZeneca1 site in 1 country98 target enrollmentJuly 11, 2005

ConditionsOvarian Neoplasms BRCA1 Protein BRCA2 Protein

InterventionsKU-0059436 (AZD2281)(PARP inhibitor)

DrugsKU-0059436 (AZD2281)(PARP inhibitor)

Overview

Phase: Phase 1
Intervention: KU-0059436 (AZD2281)(PARP inhibitor)
Conditions: Ovarian Neoplasms
Sponsor: AstraZeneca
Enrollment: 98
Locations: 1
Primary Endpoint: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 11, 2005

End Date

April 26, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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).