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Open Label, Dose Escalation Phase I Study of AZD2281

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ClinicalTrials.gov Identifier: NCT00572364
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Drug: KU-0059436 (AZD2281)(PARP inhibitor) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies
Study Start Date : November 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arms and Interventions
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Intervention Details:
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib

Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to determine the safety and tolerability of AZD2281. [ Time Frame: assessed after each visit ]

Secondary Outcome Measures :
  1. The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. [ Time Frame: assessed after each visit ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

  • Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00572364


Locations
Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: James Carmichael KuDOS/AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00572364     History of Changes
Other Study ID Numbers: D0810C00001
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009

Keywords provided by AstraZeneca:
Cancer
Advanced solid malignancies

Additional relevant MeSH terms:
Neoplasms
Poly(ADP-ribose) Polymerase Inhibitors
Olaparib
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents