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NCT00516373 Clinical Trial

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

Ovarian Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00516373
Other study ID # KU36-92
Secondary ID D0810C000022005-
Status Completed
Phase Phase 1
First received
Last updated
Start date July 11, 2005
Est. completion date April 26, 2023

Study information
Verified date February 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date April 26, 2023
Est. primary completion date December 17, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral

Locations
Country Name City State
Belgium Research Site Brussels
Netherlands Research Site Amsterdam
Poland Research Site Szczecin
United Kingdom Research Site Edinburgh
United Kingdom Research Site London

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Netherlands,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 assessed at each visit
Secondary Objective tumour response assessed every 8 weeks
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