Open Label, Dose Escalation Phase I Study of AZD2281

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Research Site
Tokyo, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	James Carmichael	KuDOS/AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Yamamoto N, Nokihara H, Yamada Y, Goto Y, Tanioka M, Shibata T, Yamada K, Asahina H, Kawata T, Shi X, Tamura T. A Phase I, dose-finding and pharmacokinetic study of olaparib (AZD2281) in Japanese patients with advanced solid tumors. Cancer Sci. 2012 Mar;103(3):504-9. doi: 10.1111/j.1349-7006.2011.02179.x. Epub 2012 Jan 30.

ClinicalTrials.gov Identifier:	NCT00572364 History of Changes
Other Study ID Numbers:	D0810C00001
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