Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

NCT00835978

Last updated date
Study Location
East Bay Medical Oncology/Hematology Medical Associates Inc.
Antioch, California, 94531, United States
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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- metastatic renal cell carcinoma (kidney cancer) with clear cell component

- no prior systemic therapy (including no prior adjuvant or neoadjuvant)

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

- Blood Pressure < or = 140/90mmHg

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


- brain/CNS metastasis


- using more than 2 blood pressure medications

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Advanced Information
Descriptive Information
Brief Title  ICMJE Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Official Title  ICMJE Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Brief Summary Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE
  • Drug: axitinib
    axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
  • Drug: axitinib
    axitinib 5mg BID (open-label) + placebo dose titration (blinded)
  • Drug: axitinib
    axitinib 5mg BID (open-label)
Study Arms  ICMJE
  • A
    Randomized arm
    Intervention: Drug: axitinib
  • B
    Randomized arm
    Intervention: Drug: axitinib
  • C
    Non-randomized arm
    Intervention: Drug: axitinib
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: September 3, 2013)
213
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2009)
200
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • metastatic renal cell carcinoma (kidney cancer) with clear cell component
  • no prior systemic therapy (including no prior adjuvant or neoadjuvant)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Blood Pressure < or = 140/90mmHg

Exclusion Criteria:

  • brain/CNS metastasis
  • using more than 2 blood pressure medications
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Czechia,   Germany,   Japan,   Russian Federation,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00835978
Other Study ID Numbers  ICMJE A4061046
2008-007786-23 ( EudraCT Number )
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 CenterPfizer
PRS Account Pfizer
Verification Date April 2017

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