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Randomized, Double-Blind Phase 2 Study of Axitinib (AG-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell

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Trial Information

Randomized, Double-Blind Phase 2 Study of Axitinib (AG-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061046

NCT ID:

NCT00835978

Start Date:

August 2009

Completion Date:

September 2013

Related Keywords:

  • Carcinoma, Renal Cell
  • axitinib or AG-013736 dose titration (increase) renal cell carcinoma
  • kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Omaha, Nebraska  68198