A Study In Patients With Advanced Solid Tumor

NCT ID: NCT00726752

Last Updated: 2012-05-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-04-30

Brief Summary

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This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses

Detailed Description

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Conditions

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Neoplasms

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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Axitinib

Group Type EXPERIMENTAL

Axitinib (AG-013736)

Intervention Type DRUG

Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Interventions

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Axitinib (AG-013736)

Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients histologically or cytologically diagnosed with advanced solid tumors
* Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
* Patients with no uncontrolled hypertension

Exclusion Criteria

* Patients who have central lung lesions involving major blood vessels
* Patients who require anticoagulant therapy.
* Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
Minimum Eligible Age

20 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

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A4061044

Identifier Type: -

Identifier Source: org_study_id

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