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

NCT00569946

Last updated date
Study Location
National Cancer Center East Hospital
Kashiwa, Chiba, 277-8577, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
Official Title  ICMJE PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER
Brief Summary To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: AG-013736
Intervention: Drug: AG-013736
Publications *

*   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: April 16, 2012)
64
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
63
Actual Study Completion Date  ICMJE October 30, 2012
Actual Primary Completion Date February 26, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT00569946
Other Study ID Numbers  ICMJE A4061035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

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