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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00338884




Registration number
NCT00338884
Ethics application status
Date submitted
16/06/2006
Date registered
20/06/2006
Date last updated
31/08/2012

Titles & IDs
Public title
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
Scientific 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
Secondary ID [1] 0 0
A6181110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate

Experimental: SUNITINIB MALATE. - Sunitinib malate starting dose 37.5 mg daily continuous daily schedule


Treatment: Drugs: Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Overall Confirmed Objective Response (OR)
Timepoint [1] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcome [1] 0 0
Duration of Response (DR)
Timepoint [1] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Secondary outcome [2] 0 0
Time to Tumor Progression (TTP)
Timepoint [2] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
Secondary outcome [4] 0 0
1-Year Survival
Timepoint [4] 0 0
From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Secondary outcome [5] 0 0
Trough Plasma Concentrations (Ctrough) of Sunitinib
Timepoint [5] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [6] 0 0
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Timepoint [6] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [7] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Timepoint [7] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [8] 0 0
Ctrough of SU-012662 (Sunitinib's Metabolite)
Timepoint [8] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [9] 0 0
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Timepoint [9] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [10] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Timepoint [10] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [11] 0 0
Ctrough of Total Drug (Sunitinib + SU-012662)
Timepoint [11] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [12] 0 0
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Timepoint [12] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [13] 0 0
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Timepoint [13] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [14] 0 0
Ctrough Correlated With Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Secondary outcome [15] 0 0
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [16] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [17] 0 0
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [17] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [18] 0 0
VEGF Ratio to Baseline at Each Time Point
Timepoint [18] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [19] 0 0
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [19] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [20] 0 0
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [20] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [21] 0 0
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [22] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [23] 0 0
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [23] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [24] 0 0
sVEGFR2 Ratio to Baseline at Each Time Point
Timepoint [24] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [25] 0 0
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Timepoint [25] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [26] 0 0
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Timepoint [26] 0 0
Baseline to Day 1 of Weeks 3 through 53
Secondary outcome [27] 0 0
Patient-Assessed Fatigue
Timepoint [27] 0 0
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)
Secondary outcome [28] 0 0
Cancer Related Symptoms, Well-Being, and Concerns
Timepoint [28] 0 0
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)

Eligibility
Key inclusion criteria
* Advanced kidney cancer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment for kidney cancer, except surgical removal of kidney tumor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [3] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa Fé
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Mexico
State/province [7] 0 0
Jalisco
Country [8] 0 0
Mexico
State/province [8] 0 0
Nuevo Leon
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taichung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Tainan
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00338884