Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137423
First received: August 26, 2005
Last updated: September 24, 2009
Last verified: September 2009
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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
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 May 23, 2013