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


filter terms:
  • adp-ribose
  • BRCA1 Protein
  • ovarian cancer
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    • Purpose

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      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.


      status: active, not recruiting
      conditions: Ovarian Neoplasms ; BRCA1 Protein ; BRCA2 Protein
      interventions: KU-0059436 (AZD2281)(PARP inhibitor)
      phase: Phase 1
      study type: Interventional
      study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
      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.

    • 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: 100

      study start date: July 2005

      study completion date: June 2010


    • Eligibility

      ages eligible for study: 18 Years and older
      genders eligible for study: Both

      Criteria

      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

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

      Locations

      Belgium  - Research Site

      facility: Brussels, Belgium

      Netherlands  - Research Site

      facility: Amsterdam, Netherlands

      Poland  - Research Site

      facility: Szczecin, Poland

      United Kingdom  - Research Site

      facility: London, United Kingdom

      United Kingdom  - Research Site

      facility: Edinburgh, United Kingdom

    • Sponsors and collaborators

      AstraZeneca
      KuDOS Pharmaceuticals Limited

      investigators: Prof James Carmichael, BSc MBChB MD FRCP, Study Director, KuDOS Pharmaceuticals Ltd
      Dr. Johann De Bono, PhD MRCP FRCR, Principal Investigator, Royal Marsden Hospital Trust, London, UK

    • More information

      first received: August 13, 2007
      last updated: September 22, 2009
      ClinicalTrials.gov Identifier: NCT00516373
      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

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

    © 2009 NextBio