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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516373
Recruitment Status : Active, not recruiting
First Posted : August 15, 2007
Last Update Posted : May 31, 2019
Information provided by (Responsible Party):

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : July 4, 2005
Actual Primary Completion Date : December 17, 2008
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arm Intervention/treatment
Experimental: KU-0059436
KU-0059436 administered orally twice daily
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib

Primary Outcome Measures :
  1. To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 [ Time Frame: assessed at each visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00516373

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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
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Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Dr. Johann De Bono, PhD MRCP FRCR Royal Marsden Hospital Trust, London, UK

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00516373     History of Changes
Other Study ID Numbers: KU36-92
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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

Additional relevant MeSH terms:
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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