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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137423
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : July 8, 2009
Last Update Posted : September 30, 2009
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Metastasis Drug: SU011248 (sunitinib) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Study Start Date : May 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SU011248 (sunitinib)
Single-arm study
 Drug: SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up ]
    Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.


Secondary Outcome Measures :
  1. Duration of Tumor Response [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up ]
    Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.

  2. Time to Tumor Progression (TTP) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up ]
    Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).

  3. Progression Free Survival (PFS) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up ]
    Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).

  4. Overall Survival [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up ]
    Overall survival is time from the date of first dose of medication to the date of death due to any cause

  5. Summary of FACIT Fatigue Scale Overall Score [ Time Frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. ]
    FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.

  6. Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index [ Time Frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. ]
    EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.

  7. Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score [ Time Frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. ]
    EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137423


Locations
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United States, California
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89135
France
Pfizer Investigational Site
Villejuif, France, 94805
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Muenchen, Germany, 81664
Greece
Pfizer Investigational Site
Thessaloniki, Greece, 56429
Netherlands
Pfizer Investigational Site
Nijmegen, Gld, Netherlands, 6525 GA
Sweden
Pfizer Investigational Site
Lund, Sweden, SE-221 85
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Switzerland
Pfizer Investigational Site
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00137423    
Other Study ID Numbers: A6181061
First Posted: August 29, 2005    Key Record Dates
Results First Posted: July 8, 2009
Last Update Posted: September 30, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action