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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 13, 2007
Last updated: November 3, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Ovarian Neoplasms
BRCA1 Protein
BRCA2 Protein
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumour response [ Time Frame: assessed every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: July 2005
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KU-0059436
KU-0059436 administered orally twice daily
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib


Ages Eligible for Study:   18 Years to 130 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516373

Research Site
Brussels, Belgium
Research Site
Amsterdam, Netherlands
Research Site
Szczecin, Poland
United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Dr. Johann De Bono, PhD MRCP FRCR Royal Marsden Hospital Trust, London, UK
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516373     History of Changes
Other Study ID Numbers: KU36-92, D0810C00002
Study First Received: August 13, 2007
Last Updated: November 3, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
advanced ovarian cancer
BRCA 1 protein
BRCA 2 protein
Poly(ADP ribose)polymerases

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2015