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A Study In Patients With Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 30, 2008
First Posted Date  ICMJE August 1, 2008
Results First Submitted Date  ICMJE February 25, 2012
Results First Posted Date  ICMJE March 26, 2012
Last Update Posted Date May 23, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2012)
  • Single Dose: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose ]
  • 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).
  • 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 ]
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
Plasma pharmacokinetics of AG-013736 following single dosing [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00726752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • 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
  • 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.
  • 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
  • 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)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
  • Adverse events [ Time Frame: End of study ]
  • Plasma pharmacokinetics of AG-013736 following multiple dosing [ Time Frame: End of study ]
  • Pharmacodynamic indices [ Time Frame: End of study ]
  • Anti-tumor effect [ Time Frame: End of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study In Patients With Advanced Solid Tumor
Official Title  ICMJE 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
Brief Summary This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Axitinib
Intervention: Drug: Axitinib (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: July 30, 2008)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726752
Other Study ID Numbers  ICMJE A4061044
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 Center Pfizer
PRS Account Pfizer
Verification Date May 2012

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