Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00338884
Ethics application status
Date submitted
16/06/2006
Date registered
19/06/2006
Date last updated
22/08/2012

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) - OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. 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.
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) - Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.
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) - Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
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) - Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
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 - One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
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 - Ctrough = the concentration prior to study drug administration.
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 - Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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 - Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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) - Ctrough = the concentration prior to study drug administration.
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) - Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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) - Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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) - Ctrough = the concentration prior to study drug administration.
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) - Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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) - Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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) - Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
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) - Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
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) - Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
Timepoint [17] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [18] 0 0
VEGF Ratio to Baseline at Each Time Point - VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
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) - Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with 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) - Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with 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) - Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
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) - Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
Timepoint [23] 0 0
Baseline (Cycle 1, Day 1)
Secondary outcome [24] 0 0
sVEGFR2 Ratio to Baseline at Each Time Point - sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
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) - Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with 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) - Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with 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 - Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
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 - FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
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
Gender
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
Blinded (masking 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00338884
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