Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

NCT ID: NCT00447005

Last Updated: 2012-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-08-31

Brief Summary

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To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.

Detailed Description

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Conditions

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Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open

Group Type EXPERIMENTAL

Axitinib (AG-013736)

Intervention Type DRUG

AG-013736 5mg twice daily \[BID\]

Interventions

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Axitinib (AG-013736)

AG-013736 5mg twice daily \[BID\]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients histologically or cytologically diagnosed with advanced malignant solid tumors
* Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies

Exclusion Criteria

* Central lung lesions involving major blood vessels
* Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kashiwa, Chiba, Japan

Site Status

Countries

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Japan

References

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Mukohara T, Nakajima H, Mukai H, Nagai S, Itoh K, Umeyama Y, Hashimoto J, Minami H. Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients. Cancer Sci. 2010 Apr;101(4):963-8. doi: 10.1111/j.1349-7006.2009.01465.x. Epub 2009 Dec 9.

Reference Type DERIVED
PMID: 20180805 (View on PubMed)

Related Links

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Other Identifiers

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A4061022

Identifier Type: -

Identifier Source: org_study_id

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