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NCT00089648 Clinical Trial

SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:
A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00089648
Other study ID # A6181039
Secondary ID
Status Completed
Phase Phase 2
First received August 9, 2004
Last updated January 6, 2010
Start date December 2004
Est. completion date March 2008

Study information
Verified date January 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date March 2008
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Duarte California
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Pasadena California
United States Pfizer Investigational Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up No
Secondary Time to Tumor Progression (TTP) 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up No
Secondary Duration of Response (DR) 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up No
Secondary Overall Survival (OS) 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up No
Secondary Progression Free Survival (PFS) 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up No
Secondary Trough Plasma Concentrations (Cmin) of Sunitinib Day 28 of Cycle 1 to Cycle 4 No
Secondary Trough Plasma Concentrations (Cmin) of SU012662 Day 28 of Cycle 1 to Cycle 4 No
Secondary Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662) Day 28 of Cycle 1 to Cycle 4 No
Secondary Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A) Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1) No
Secondary Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1) No
Secondary Plasma Concentration of Placental Growth Factor (PlGF) Cycle 1 (Days 1, 14, and 28) No
Secondary Plasma Concentration of VEGF-C Cycle 1 (Days 1, 14, and 28) No
Secondary Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2) 1 year No
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