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

NCT00516373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-02-22

No results posted yet for this study

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

Conditions

  • Ovarian Neoplasms
  • BRCA1 Protein
  • BRCA2 Protein

Interventions

DRUG

KU-0059436 (AZD2281)(PARP inhibitor)

oral

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson, BSc, MBCHB, MD · AstraZeneca

  • Dr. Johann De Bono, PhD MRCP FRCR · Royal Marsden Hospital Trust, London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-11
Primary Completion
2008-12-17
Completion
2023-04-26

Countries

  • Belgium
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516373 on ClinicalTrials.gov