A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

NCT ID: NCT00503477

Last Updated: 2009-06-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-01-31

Brief Summary

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A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AZD2171

oral tablet

Intervention Type DRUG

Other Intervention Names

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cediranib RECENTIN™

Eligibility Criteria

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Inclusion Criteria

* advanced solid tumors
* life expectancy is 12 weeks or longer

Exclusion Criteria

* patient with uncontrolled brain metastases
* patient with inappropriate laboratory test values
* patient with poorly controlled hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 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

Principal Investigators

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Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Tomohide Tamura, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre Hospital, Tokyo

Locations

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Research Site

Shizuoka, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D8480C00023

Identifier Type: -

Identifier Source: org_study_id

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