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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Francisco, California, 94115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT01469052
Pfizer
Completed
First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

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[email protected]

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First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: 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
  • Drug: AG-013736
    Axitinib continuous oral dosing (20 mg twice a day) in the fed state
  • Drug: AG-013736
    Axitinib continuous oral dosing (5 mg twice a day) in the fed state
  • Drug: AG-013736
    Axitinib continuous oral dosing (15 mg once a day) in the fed state
  • Drug: AG-013736
    Axitinib continuous oral dosing (5 mg twice a day) in the fasted state
  • 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
  • Experimental: Cohort 1
    Intervention: Drug: AG-013736
  • Experimental: Cohort 2
    Intervention: Drug: AG-013736
  • Experimental: Cohort 3
    Intervention: Drug: AG-013736
  • Experimental: Cohort 4
    Intervention: Drug: AG-013736
  • Experimental: Cohort 5
    Intervention: Drug: AG-013736
  • Experimental: Cohort 6
    Intervention: Drug: AG-013736
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2004
July 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01469052
AG013736-001
A4060010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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