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

NCT00089648 | Completed Phase 2 Results

• 1 other identifier: A6181039
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)

  Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up

Secondary Outcomes (12)

• 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

• 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

• 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

• 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

• Trough Plasma Concentrations (Cmin) of Sunitinib

  Day 28 of Cycle 1 to Cycle 4

Study Arms (1)

1

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

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

Also known as: SUTENT, SU011248,

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Pfizer Investigational Site

Duarte, California, 91010, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637-1460, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-5536, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2004
• First Posted: August 11, 2004
• Study Start: December 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 12, 2010
• Results First Posted: December 21, 2009

Record last verified: 2010-01

Locations

US (11)