Open Label, Dose Escalation Phase I Study of AZD2281

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: NCT00572364
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : August 20, 2009
Information provided by:

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 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

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

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 ]

Information from the National Library of Medicine

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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

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.

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): NCT00572364

Research Site
Tokyo, Japan
Sponsors and Collaborators
Study Director: James Carmichael KuDOS/AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): 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:
Advanced solid malignancies

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