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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00516373
Collaborator
(none)
98
Enrollment
5
Locations
1
Arm
209.6
Anticipated Duration (Months)
19.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Non-Randomized
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 :
Jul 11, 2005
Actual Primary Completion Date :
Dec 17, 2008
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: KU-0059436

KU-0059436 administered orally twice daily

Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Names:
  • Olaparib

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Objective tumour response [assessed every 8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Brussels Belgium 1090
    2 Research Site Amsterdam Netherlands 1066 CX
    3 Research Site Szczecin Poland 70-115
    4 Research Site Edinburgh United Kingdom EH4 2XR
    5 Research Site London United Kingdom SM2 5NG

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00516373
    Other Study ID Numbers:
    • KU36-92
    • D0810C00002
    First Posted:
    Aug 15, 2007
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by AstraZeneca
    advanced ovarian cancer
    BRCA 1 protein
    BRCA 2 protein
    Poly(ADP ribose)polymerases
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Olaparib
    Poly(ADP-ribose) Polymerase Inhibitors

    Study Results

    No Results Posted as of Jun 3, 2022