You are here

Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Stanford, California, 94305 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Metastasis 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

- Histologically proven renal cell carcinoma with metastases.

- Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in
Solid Tumors (RECIST).

- Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated
with IFN-á alone must have received IFN-á for at least 4 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

- Resolution of all acute toxic effects of prior therapy or surgical procedures to grade
1.

- Adequate organ function

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

- Prior treatment with any systemic therapy other than 1 cytokine-based therapy.

- Previous treatment on a SU011248 (sunitinib) clinical trial.

- Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the
study treatment.

- Diagnosis of any second malignancy within the last 3 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
treated with no evidence of recurrent disease for 12 months.

- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease on screening Computed
Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.

- Any of the following within the 12 months prior to starting the study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident or transient ischemic
attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
interval >450 msec for males or >470 msec for females.

- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).

- Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to
2 mg PO daily for deep vein thrombosis prophylaxis is allowed).

- Known human immunodeficiency virus (HIV) infection.

NCT00137423
Pfizer
Completed
Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

NEED INFO?

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

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 city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
Official Title  ICMJE A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Brief SummaryTo evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell Metastasis
Intervention  ICMJE Drug: SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing
Study Arms  ICMJE Experimental: SU011248 (sunitinib)
Single-arm study
Intervention: Drug: SU011248 (sunitinib)
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: December 21, 2007)
107
Original Enrollment  ICMJE
 (submitted: August 26, 2005)
100
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion DateSeptember 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven renal cell carcinoma with metastases.
  • Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
  • Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1.
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
  • Previous treatment on a SU011248 (sunitinib) clinical trial.
  • Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
  • Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
  • Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Known human immunodeficiency virus (HIV) infection.
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 France,   Germany,   Greece,   Netherlands,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137423
Other Study ID Numbers  ICMJE A6181061
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2009

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now