First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-08-31

Brief Summary

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The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state

Cohort 2

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (20 mg twice a day) in the fed state

Cohort 3

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (5 mg twice a day) in the fed state

Cohort 4

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (15 mg once a day) in the fed state

Cohort 5

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (5 mg twice a day) in the fasted state

Cohort 6

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state

Interventions

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AG-013736

Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state

Intervention Type DRUG

AG-013736

Axitinib continuous oral dosing (20 mg twice a day) in the fed state

Intervention Type DRUG

AG-013736

Axitinib continuous oral dosing (5 mg twice a day) in the fed state

Intervention Type DRUG

AG-013736

Axitinib continuous oral dosing (15 mg once a day) in the fed state

Intervention Type DRUG

AG-013736

Axitinib continuous oral dosing (5 mg twice a day) in the fasted state

Intervention Type DRUG

AG-013736

Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
* Patients with adequate bone marrow, liver and kidney function
* Patients with life expectancy of at least 12 weeks

Exclusion Criteria

* Patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry
* Patients with have had a major surgical procedure within 4 weeks of study entry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No