Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Carcinoma, Renal Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338884
• Other study ID #: A6181110
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2006
• Last updated: August 22, 2012
• Start date: September 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Advanced kidney cancer

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Rosario	Santa Fé
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Clayton	Victoria
Australia	Pfizer Investigational Site	East Bentleigh	Victoria
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	São Paulo	SP
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Korea, Republic of,  Mexico,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter	No
Secondary	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.	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause	No
Secondary	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.	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter	No
Secondary	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.	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death	No
Secondary	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.	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year	No
Secondary	Trough Plasma Concentrations (Ctrough) of Sunitinib	Ctrough = the concentration prior to study drug administration.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	Ctrough of SU-012662 (Sunitinib's Metabolite)	Ctrough = the concentration prior to study drug administration.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	Ctrough of Total Drug (Sunitinib + SU-012662)	Ctrough = the concentration prior to study drug administration.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	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.	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	No
Secondary	Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline		Baseline	No
Secondary	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.	Baseline (Cycle 1, Day 1)	No
Secondary	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.	Baseline (Cycle 1, Day 1)	No
Secondary	VEGF Ratio to Baseline at Each Time Point	VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	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).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	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).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline		Baseline	No
Secondary	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.	Baseline (Cycle 1, Day 1)	No
Secondary	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.	Baseline (Cycle 1, Day 1)	No
Secondary	sVEGFR2 Ratio to Baseline at Each Time Point	sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	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).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	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).	Baseline to Day 1 of Weeks 3 through 53	No
Secondary	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.	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)	No
Secondary	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.	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)	No

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