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Trial record 1 of 1 for:    00447005
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Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00447005
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : March 26, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma Drug: Axitinib (AG-013736) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors
Study Start Date : February 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Drug: Axitinib (AG-013736)
AG-013736 5mg twice daily [BID]


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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).

  4. 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.

  5. 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 ]
  6. 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 ]
  7. 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.

  8. 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)

  9. 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.

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447005


Locations
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Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00447005    
Other Study ID Numbers: A4061022
First Posted: March 13, 2007    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Pfizer:
Safety
PK
Biomarker
Additional relevant MeSH terms:
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Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action