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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00338884
First received: June 16, 2006
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sunitinib malate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Overall Confirmed Objective Response (OR) [ Time Frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Duration of Response (DR) [ Time Frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause ] [ Designated as safety issue: No ]
    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.

  • Time to Tumor Progression (TTP) [ Time Frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter ] [ Designated as safety issue: No ]
    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.

  • Progression-Free Survival (PFS) [ Time Frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death ] [ Designated as safety issue: No ]
    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.

  • 1-Year Survival [ Time Frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year ] [ Designated as safety issue: No ]
    One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.

  • Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration.

  • Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

  • Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

  • Ctrough of SU-012662 (Sunitinib's Metabolite) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration.

  • Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

  • Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

  • Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration.

  • Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

  • Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

  • Ctrough Correlated With Serious Adverse Events (SAEs) [ Time Frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 ] [ Designated as safety issue: No ]
    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.

  • Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) [ Time Frame: Baseline (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
    Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.

  • VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) [ Time Frame: Baseline (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
    Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.

  • VEGF Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).

  • VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    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).

  • VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    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).

  • Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) [ Time Frame: Baseline (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
    Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.

  • sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) [ Time Frame: Baseline (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
    Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.

  • sVEGFR2 Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).

  • sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    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).

  • sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) [ Time Frame: Baseline to Day 1 of Weeks 3 through 53 ] [ Designated as safety issue: No ]
    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).

  • Patient-Assessed Fatigue [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Cancer Related Symptoms, Well-Being, and Concerns [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: September 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUNITINIB MALATE.
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Drug: Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced kidney cancer

Exclusion Criteria:

  • Previous treatment for kidney cancer, except surgical removal of kidney tumor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338884

Locations
Argentina
Pfizer Investigational Site
Rosario, Santa Fé, Argentina, (2000)
Pfizer Investigational Site
Buenos Aires, Argentina, 1431
Pfizer Investigational Site
Cordoba, Argentina, X5000AAI
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
Clayton, Victoria, Australia, 3168
Pfizer Investigational Site
East Bentleigh, Victoria, Australia, 3165
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 01308-050
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44280
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Taiwan
Pfizer Investigational Site
Taichung, Taiwan, 407
Pfizer Investigational Site
Tainan, Taiwan, 710
Pfizer Investigational Site
Taipei, Taiwan, 112
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00338884     History of Changes
Other Study ID Numbers: A6181110
Study First Received: June 16, 2006
Results First Received: April 20, 2010
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014