AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

NCT ID: NCT00704366

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-05-31

Brief Summary

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This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD0530

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

oral, tablet, once daily, dose will be variable

Interventions

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AZD0530

oral, tablet, once daily, dose will be variable

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
* World Health Organisation (WHO) performance status 0 to 2
* Life expectancy of at least 12 weeks

Exclusion Criteria

* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low hemoglobin
* Unresolved toxicity from anti-cancer therapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Mary Stuart, MD

Role: STUDY_CHAIR

AstraZeneca

Narikazu Boku, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Marianna University School of Medicine

Locations

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Research Site

Takatsuk, Osaka, Japan

Site Status

Research Site

Sunto-gun, Shizuoka, Japan

Site Status

Countries

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Japan

References

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Fujisaka Y, Onozawa Y, Kurata T, Yasui H, Goto I, Yamazaki K, Machida N, Watanabe J, Shimada H, Shi X, Boku N. First report of the safety, tolerability, and pharmacokinetics of the Src kinase inhibitor saracatinib (AZD0530) in Japanese patients with advanced solid tumours. Invest New Drugs. 2013 Feb;31(1):108-14. doi: 10.1007/s10637-012-9809-7. Epub 2012 Mar 14.

Reference Type DERIVED
PMID: 22415795 (View on PubMed)

Other Identifiers

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D8180C00021

Identifier Type: -

Identifier Source: org_study_id

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