Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A4061035
Previous Study | Return to List | Next Study

Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

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: NCT00569946
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : March 27, 2012
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: AG-013736 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER
Actual Study Start Date : December 12, 2007
Actual Primary Completion Date : February 26, 2010
Actual Study Completion Date : October 30, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arm Intervention/treatment
Experimental: AG-013736 Drug: AG-013736

AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.

Number of cycles: until progression or unacceptable toxicity develops.





Primary Outcome Measures :
  1. Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment [ Time Frame: Up to 765 days of treatment at the data cut-off date ]
    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). 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 of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

  2. Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment [ Time Frame: Up to 765 days of treatment at the data cut-off date ]
    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). 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 of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 1709 days of treatment ]
    Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).

  2. Time to Tumor Progression (TTP) [ Time Frame: Up to 1709 days of treatment ]
    Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).

  3. Duration of Response [ Time Frame: Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days. ]
    Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  4. Overall Survival (OS) [ Time Frame: Up to 2002 days (maximum duration of treatment plus follow-up observation) ]

    OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.

    Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive.


  5. Number of Participants Analyzed for Population Pharmacokinetics of AG-013736 [ Time Frame: Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose ]
    Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.

  6. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1) [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days) ]
  7. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2) [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days) ]
  8. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3) [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days) ]
  9. Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT) [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days) ]
  10. Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days) ]
  11. Number of Participants With Adverse Events [ Time Frame: Up to 1709 days of treatment plus 28-days follow-up ]
    Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
  • Patients who are refractory to cytokine therapy as 1st line.
  • Patients who experienced nephrectomy.
  • Patients with at least 1 target lesion, as defined by RECIST.
  • Patients with no uncontrolled hypertension.

Exclusion Criteria:

  • Gastrointestinal abnormalities
  • Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
  • Active seizure disorder or evidence of brain metastases.
  • Patients with hemoptysis.

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): NCT00569946


Locations
Layout table for location information
Japan
National Cancer Center East Hospital
Kashiwa, Chiba, Japan, 277-8577
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Medical University
Morioka, Iwate, Japan, 020-8505
Kochi Medical School Hospital
Nankoku-shi, Kochi-ken, Japan, 783-8505
Kinki University Hospital
Osakasayama, Osaka, Japan, 589-8511
Hamamatsu University School of Medicine University Hospital
Hamamatsu-City, Shizuoka, Japan, 431-3192
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, Japan, 116-8567
National Cancer Center
Chuo-ku, Tokyo, Japan, 104-8503
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Akita University Hospital
Akita, Japan, 010-8543
National Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital, Department of Urology
Fukuoka, Japan, 812-8582
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Osaka University Hospital
Osaka, Japan, 565-0871
Tokushima University Hospotal
Tokushima, Japan, 770-8503
Yamagata University Hospital
Yamagata, Japan, 990-9585
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00569946     History of Changes
Other Study ID Numbers: A4061035
First Posted: December 10, 2007    Key Record Dates
Results First Posted: March 27, 2012
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:
AG-013736
RCC
Phase 2

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action