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Open Label, Dose Escalation Phase I Study of AZD2281

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00572364
First received: December 12, 2007
Last updated: August 19, 2009
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572364

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00572364     History of Changes
Other Study ID Numbers: D0810C00001
Study First Received: December 12, 2007
Last Updated: August 19, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Cancer
Advanced solid malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013