Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Sunitinib malate

Pfizer CT.gov Call Center

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.

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

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

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.

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 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.

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.

One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.

Ctrough = the concentration prior to study drug administration.

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

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.

Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.

Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.

VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).

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).

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).

Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.

Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.

sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).

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).

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).

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.

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.

Pfizer

The same event may appear as both an adverse event (AE) and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.

18 to 44 years

45 to 64 years

> = 65 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.

Number of Subjects With Overall Confirmed Objective Response (OR)

Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.

Duration of Response (DR)

Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.

Time to Tumor Progression (TTP)

Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.

Progression-Free Survival (PFS)

Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.

1-Year Survival

Day 1, Week 1 (n=111)

Day 1, Week 3 (n=108)

Day 1, Week 5 (n=106)

Day 1, Week 7 (n=104)

Day 1, Week 9 (n=97)

Day 1, Week 13 (n=93)

Day 1, Week 17 (n=82)

Day 1, Week 21 (n=73)

Day 1, Week 25 (n=70)

Day 1, Week 29 (n=58)

Day 1, Week 33 (n=58)

Day 1, Week 37 (n=50)

Day 1, Week 41 (n=49)

Day 1, Week 45 (n=44)

Day 1, Week 49 (n=40)

Day 1, Week 53 (n=33)

Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Trough Plasma Concentrations (Ctrough) of Sunitinib

Day 1, Week 1 (CR or PR, n=39)

Day 1, Week 3 (CR or PR, n=40)

Day 1, Week 5 (CR or PR, n=38)

Day 1, Week 7 (CR or PR, n=40)

Day 1, Week 9 (CR or PR, n=38)

Day 1, Week 13 (CR or PR, n=41)

Day 1, Week 17 (CR or PR, n=38)

Day 1, Week 21 (CR or PR, n=38)

Day 1, Week 25 (CR or PR, n=37)

Day 1, Week 29 (CR or PR, n=32)

Day 1, Week 33 (CR or PR, n=33)

Day 1, Week 37 (CR or PR, n=28)

Day 1, Week 41 (CR or PR, n=28)

Day 1, Week 45 (CR or PR, n=29)

Day 1, Week 49 (CR or PR, n=26)

Day 1, Week 53 (CR or PR, n=21)

Day 1, Week 1 (PD, n=16)

Day 1, Week 3 (PD, n=15)

Day 1, Week 5 (PD, n=15)

Day 1, Week 7 (PD, n=13)

Day 1, Week 9 (PD, n=8)

Day 1, Week 13 (PD, n=1)

Day 1, Week 17 (PD, n=1)

Day 1, Week 21 (PD, n=1)

Day 1, Week 25 (PD, n=1)

Day 1, Week 29 (PD, n=1)

Day 1, Week 33 (PD, n=1)

PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.

Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib

Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)

Day 1, Week 1 (CR or PR or SD, n=83)

Day 1, Week 3 (CR or PR or SD, n=83)

Day 1, Week 5 (CR or PR or SD, n=83)

Day 1, Week 7 (CR or PR or SD, n=86)

Day 1, Week 9 (CR or PR or SD, n=85)

Day 1, Week 13 (CR or PR or SD, n=88)

Day 1, Week 17 (CR or PR or SD, n=79)

Day 1, Week 21 (CR or PR or SD, n=71)

Day 1, Week 25 (CR or PR or SD, n=68)

Day 1, Week 29 (CR or PR or SD, n=56)

Day 1, Week 33 (CR or PR or SD, n=56)

Day 1, Week 37 (CR or PR or SD, n=49)

Day 1, Week 41 (CR or PR or SD, n=49)

Day 1, Week 45 (CR or PR or SD, n=44)

Day 1, Week 49 (CR or PR or SD, n=40)

Day 1, Week 53 (CR or PR or SD, n=32)

Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib

PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Ctrough of SU-012662 (Sunitinib's Metabolite)

Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)

Ctrough of Total Drug (Sunitinib + SU-012662)

Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)

Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.

Ctrough Correlated With Serious Adverse Events (SAEs)

Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.

Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline

Cycle 1, Day 1 (CR or PR, n=39)

Cycle 1, Day 1 (PD, n=16)

Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)

Cycle 1, Day 1 (CR or PR or SD, n=85)

VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Day 1, Week 5 (n=104)

Day 1, Week 7 (n=101)

Day 1, Week 9 (n=95)

Day 1, Week 13 (n=91)

Day 1, Week 17 (n=78)

Day 1, Week 21 (n=70)

Day 1, Week 25 (n=67)

Day 1, Week 29 (n=55)

Day 1, Week 33 (n=54)

Day 1, Week 37 (n=49)

Day 1, Week 41 (n=48)

Day 1, Week 45 (n=41)

Day 1, Week 49 (n=37)

Day 1, Week 53 (n=30)

Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.

VEGF Ratio to Baseline at Each Time Point

Day 1, Week 3 (CR or PR, n=38)

Day 1, Week 5 (CR or PR, n=37)

Day 1, Week 7 (CR or PR, n=39)

Day 1, Week 9 (CR or PR, n=37)

Day 1, Week 13 (CR or PR, n=39)

Day 1, Week 13 (PD, n=2)

Day 1, Week 17 (CR or PR, n=36)

Day 1, Week 21 (CR or PR, n=36)

Day 1, Week 25 (CR or PR, n=35)

Day 1, Week 29 (CR or PR, n=30)

Day 1, Week 33 (CR or PR, n=31)

Day 1, Week 45 (CR or PR, n=27)

Day 1, Week 49 (CR or PR, n=24)

Day 1, Week 53 (CR or PR, n=19)

Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.

Spots Global Cancer Trial Database for Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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