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Open Label, Dose Escalation Phase I Study of AZD2281

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572364
First Posted: December 13, 2007
Last Update Posted: August 20, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Advanced Solid Malignancies Drug: KU-0059436 (AZD2281)(PARP inhibitor) Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 18
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
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
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

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 Submitted: December 12, 2007
First Posted: December 13, 2007
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