Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
NCT00137423
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- 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
- 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.
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| 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 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 | |||
| Detailed Description | Not 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 | 107 | |||
| Original Enrollment ICMJE | 100 | |||
| Actual Study Completion Date ICMJE | May 2008 | |||
| Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||