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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Central lung lesions involving major blood vessels

- Patients who have been treated with bevacizumab or other VEGFR inhibitor(s)

NCT00447005
Pfizer
Completed
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
Brief SummaryTo 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma
Intervention  ICMJE Drug: Axitinib (AG-013736)
AG-013736 5mg twice daily [BID]
Study Arms  ICMJE Experimental: Open
Intervention: Drug: Axitinib (AG-013736)
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2007)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion DateAugust 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447005
Other Study ID Numbers  ICMJE A4061022
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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