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

May 17, 2012 updated by: Pfizer

A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open
Drug: Axitinib (AG-013736)
AG-013736 5mg twice daily [BID]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Up to 795 days of treatment plus 28-days follow-up
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.
Up to 795 days of treatment plus 28-days follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax): Single Dose
Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose
Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose
Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Terminal Phase Plasma Half-Life (t1/2): Single Dose
Time Frame: Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
t1/2 is the time measured for the plasma concentration to decrease by one half.
Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose
Maximum Observed Plasma Concentration (Cmax): Multiple Dose
Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose
Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose
Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Dosing Interval was 12 hours in this study.
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose
Time Frame: Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)
Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose
Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)
Time Frame: Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation
Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.
Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation
The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)
Time Frame: Up to 795 days
CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
Up to 795 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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