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

NCT01469052

Last updated date
Study Location
Pfizer Investigational Site
San Francisco, California, 94115, United States
Contact
1-800-718-1021

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1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
Official Title  ICMJE Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   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: November 7, 2011)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01469052
Other Study ID Numbers  ICMJE AG013736-001
A4060010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP