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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137423
First received: August 26, 2005
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell Metastasis
Drug: SU011248 (sunitinib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: May 2005
Study Completion Date: May 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SU011248 (sunitinib)
Single-arm study
Drug: SU011248 (sunitinib)
37.5 mg/day, oral, continuous daily dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137423

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00137423     History of Changes
Other Study ID Numbers: A6181061
Study First Received: August 26, 2005
Results First Received: May 14, 2009
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014