NCT00447005

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2.5 years

First QC Date

March 12, 2007

Results QC Date

February 25, 2012

Last Update Submit

May 17, 2012

Conditions

Carcinoma

Keywords

SafetyPKBiomarker

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    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 Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax): Single Dose

    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

    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

    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

    Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose

  • Maximum Observed Plasma Concentration (Cmax): Multiple Dose

    Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose

  • +5 more secondary outcomes

Study Arms (1)

Open

EXPERIMENTAL
Drug: Axitinib (AG-013736)

Interventions

Axitinib (AG-013736)DRUG

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

Open

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Location

Related Publications (1)

  • 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.

    PMID: 20180805DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

February 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 23, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-05

Locations

JP(1)