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

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NCT00835978

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
East Bay Medical Oncology/Hematology Medical Associates Inc.
Antioch, California, 94531 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

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

NCT00835978
Pfizer
Completed
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

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Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoma, Renal Cell
  • 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)
  • A
    Randomized arm
    Intervention: Drug: axitinib
  • B
    Randomized arm
    Intervention: Drug: axitinib
  • C
    Non-randomized arm
    Intervention: Drug: axitinib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
February 2016
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czechia,   Germany,   Japan,   Russian Federation,   Spain,   United States
Czech Republic
 
NCT00835978
A4061046
2008-007786-23 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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