You are here

Our science / Clinical Trials / Find a Trial / NCT00835978

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

Back to Search Print Save as PDF Bookmark Trial

NCT00835978

Last updated on August 9, 2018
Back to Search Print Save as PDF Bookmark Trial

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Renal Impairment
Lorlatinib Renal Impairment Study
NCT03542305
All Genders
18+
Years
Multiple Sites
Squamous Cell Carcinoma of the Head and Neck
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
NCT02952586
All Genders
18+
Years
Multiple Sites
Non-Small-Cell Lung Carcinoma
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
NCT03052608
All Genders
18+
Years
Multiple Sites
Hepatocellular Carcinoma
A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
NCT03289533
All Genders
20+
Years
Multiple Sites
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now