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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):
AstraZeneca Identifier:
First received: August 13, 2007
Last updated: March 29, 2017
Last verified: March 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Objective tumour response [ Time Frame: assessed every 8 weeks ]

Enrollment: 95
Actual Study Start Date: July 4, 2005
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: December 17, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00516373     History of Changes
Other Study ID Numbers: KU36-92
Study First Received: August 13, 2007
Last Updated: March 29, 2017

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 26, 2017