Clinical trial NCT00077974: A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
Official title: A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-02-18
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma


Eligibility criteria: Inclusion Criteria:

* Cytokine refractory metastatic renal cell carcinoma with clear cell component
* Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
* Prior nephrectomy

Exclusion Criteria:

* Prior treatment with any systemic therapy other than 1 cytokine therapy
* History of or known brain metastases
* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Primary outcomes:
measure: Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
timeFrame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
measure: Duration of Response (DR)
timeFrame: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
measure: Overall Survival (OS)
timeFrame: From start of study treatment until death
measure: Progression-free Survival (PFS)
timeFrame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
measure: Percent Chance of Patient Survival
timeFrame: From start of study treatment until death
measure: Observed Plasma Trough Concentrations of Sunitinib
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
measure: Observed Plasma Trough Concentrations of Sunitinib Metabolite
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
measure: Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
measure: Dose Corrected Plasma Trough Concentrations of Sunitinib
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
measure: Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
measure: Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
timeFrame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
citation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
citation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
citation: Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.