Clinical trial NCT00338884: Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Official title: A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.


Eligibility criteria: Inclusion Criteria:

* Advanced kidney cancer

Exclusion Criteria:

* Previous treatment for kidney cancer, except surgical removal of kidney tumor

Primary outcomes:
measure: Number of Subjects With Overall Confirmed Objective Response (OR)
timeFrame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcomes:
measure: Duration of Response (DR)
timeFrame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
measure: Time to Tumor Progression (TTP)
timeFrame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
measure: Progression-Free Survival (PFS)
timeFrame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
measure: 1-Year Survival
timeFrame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
measure: Trough Plasma Concentrations (Ctrough) of Sunitinib
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough of SU-012662 (Sunitinib's Metabolite)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough of Total Drug (Sunitinib + SU-012662)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Ctrough Correlated With Serious Adverse Events (SAEs)
timeFrame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
measure: Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
timeFrame: Baseline
measure: VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
timeFrame: Baseline (Cycle 1, Day 1)
measure: VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1)
measure: VEGF Ratio to Baseline at Each Time Point
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
timeFrame: Baseline
measure: sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
timeFrame: Baseline (Cycle 1, Day 1)
measure: sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
timeFrame: Baseline (Cycle 1, Day 1)
measure: sVEGFR2 Ratio to Baseline at Each Time Point
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
timeFrame: Baseline to Day 1 of Weeks 3 through 53
measure: Patient-Assessed Fatigue
timeFrame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
measure: Cancer Related Symptoms, Well-Being, and Concerns
timeFrame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fé
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: East Bentleigh
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
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: Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.