SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00089648
First received: August 9, 2004
Last updated: January 6, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: 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 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Tumor Progression (TTP) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up ] [ Designated as safety issue: No ]
- Duration of Response (DR) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 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 including 28 day post study follow up ] [ Designated as safety issue: No ]
- Trough Plasma Concentrations (Cmin) of Sunitinib [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]
- Trough Plasma Concentrations (Cmin) of SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]
- Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662) [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]
- Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A) [ Time Frame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) [ Time Frame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1) ] [ Designated as safety issue: No ]
- Plasma Concentration of Placental Growth Factor (PlGF) [ Time Frame: Cycle 1 (Days 1, 14, and 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of VEGF-C [ Time Frame: Cycle 1 (Days 1, 14, and 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | December 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Sunitinib
50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
Other Name: SUTENT, SU011248,
|
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 of clear cell histology with metastases
- Evidence of measurable disease
- Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
- Prior radical or partial nephrectomy
Exclusion Criteria:
- Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- Prior systemic treatment for RCC > 2 regimens
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089648
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Duarte, California, United States, 91010 | |
| Pfizer Investigational Site | |
| Pasadena, California, United States, 91105 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60637-1460 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232-5536 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00089648 History of Changes |
| Other Study ID Numbers: | A6181039 |
| Study First Received: | August 9, 2004 |
| Results First Received: | November 16, 2009 |
| Last Updated: | January 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 Bevacizumab Sunitinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013