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A Study In Patients With Advanced Solid Tumor

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ClinicalTrials.gov Identifier: NCT00726752
Recruitment Status : Completed
First Posted : August 1, 2008
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:
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
Study Start Date : July 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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: Axitinib Drug: Axitinib (AG-013736)
Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.


Outcome Measures
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Primary Outcome Measures :
  1. Single Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
    AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).

  3. Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
  4. Single Dose: Plasma Decay Half-Life (t1/2) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Secondary Outcome Measures :
  1. Multiple Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
    Cmax at multiple dosing

  2. Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
    The dosing interval was 12 hours in this study.

  3. Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose ]
    Tmax at multiple dosing

  4. Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau) [ Time Frame: Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour 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)

  5. Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, 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) and Day 1 of Cycle 2 ]
    Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF

  6. Number 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 470 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.

  7. Number of Participants With Adverse Events [ Time Frame: Up to 470 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 (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.


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

Inclusion Criteria:

  • Patients histologically or cytologically diagnosed with advanced solid tumors
  • Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  • Patients with no uncontrolled hypertension

Exclusion Criteria:

  • Patients who have central lung lesions involving major blood vessels
  • Patients who require anticoagulant therapy.
  • Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
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): NCT00726752


Locations
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Japan
Pfizer Investigational Site
Kobe-shi, Hyogo-ken, 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:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00726752    
Other Study ID Numbers: A4061044
First Posted: August 1, 2008    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Pfizer:
solid tumor
Axitinib
Pharmacokinetics
Phase 1
Additional relevant MeSH terms:
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Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action