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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00447005
First received: March 12, 2007
Last updated: May 17, 2012
Last verified: May 2012
History of Changes

March 12, 2007
May 17, 2012
February 2007
August 2009   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events [ Time Frame: Up to 795 days of treatment plus 28-days follow-up ] [ Designated as safety issue: Yes ]
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.
The incidence of all adverse events by type and grade, Abnormal laboratory changes(every 2 weeks)
Complete list of historical versions of study NCT00447005 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).
  • 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 ] [ Designated as safety issue: No ]
    t1/2 is the time measured for the plasma concentration to decrease by one half.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Dosing Interval was 12 hours in this study.
  • 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 ] [ Designated as safety issue: No ]
    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)
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
Pharmacokinetics (at single dosing, 1st ,15th and 29th day of multiple dosing following single dosing) Pharmacodynamic indices (4 times every 4 weeks and end of treatment) Anti-tumor activity (every 8 weeks until end of treatment)
Not Provided
Not Provided
 
Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors
A Phase 1 Study Of AG-013736 (Axitinib) In Japanese Patients With Advanced Solid Tumors

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma
Drug: Axitinib (AG-013736)
AG-013736 5mg twice daily [BID]
Experimental: Open
Intervention: Drug: Axitinib (AG-013736)
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. Epub 2009 Dec 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00447005
A4061022
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

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