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

Pfizer1 site in 1 country61 target enrollmentDecember 2004

ConditionsCarcinoma, Renal Cell

InterventionsSunitinib

DrugsSunitinib

Overview

Phase: Phase 2
Intervention: Sunitinib
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Enrollment: 61
Locations: 1
Primary Endpoint: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

March 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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

Arms & Interventions

1

Intervention: Sunitinib

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

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)
Trough Plasma Concentrations (Cmin) of SU012662(Day 28 of Cycle 1 to Cycle 4)
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)(Day 28 of Cycle 1 to Cycle 4)
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)(Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1))
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)(Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1))
Plasma Concentration of Placental Growth Factor (PlGF)(Cycle 1 (Days 1, 14, and 28))
Plasma Concentration of VEGF-C(Cycle 1 (Days 1, 14, and 28))
Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)(1 year)