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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00089648
First received: August 9, 2004
Last updated: January 6, 2010
Last verified: January 2010
  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
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: 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 July 29, 2014