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 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:

Drug Information available for: Olaparib

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 ]

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:

oral

Other Name: Olaparib

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received:	December 12, 2007
Last Updated:	August 19, 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

ClinicalTrials.gov processed this record on August 18, 2017

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