Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Rare Diseases

Kidney Diseases

Carcinoma

Carcinoma, Renal Cell

Urogenital Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Sutent: observational study

Pfizer CT.gov Call Center

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

The Statistical Analysis Plan provides detailed specification of the analysis

SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer

Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. 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.

TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.

ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status

EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems

Pfizer

Director, Clinical Trial Disclosure Group

The same event may appear as both an 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.

Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.

18 to 44 Years

45 to 64 Years

>=65 Years

Unspecified

Age, Customized

Male

Female

Sex/Gender, Customized

Owing to extent of missing data, the planned TTP analyses derived from standardized lesion measurement was not reported. An additional TTP analysis using Investigator Disease Status and Overall Objective Tumor Assessments at 12 months was reported.

Pfizer ClinicalTrials.gov Call Center

Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR

Complete Response (CR)

Partial Response (PR)

Stable Disease/No Response

Progressive Disease (PD)

Indeterminate

Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement

Number of Participants With Categorical Best Overall Response

Number of Participants With Objective Response

FAS. Number of participants with progression = 162; Number of participants censored = 190

Time to Progression (TTP)

Fully Active (Baseline)

Restricted Physical Strenuous Activity (Baseline)

Capable of Self Care Only (Baseline)

Capable of Limited Self Care Only (Baseline)

Completely Disabled (Baseline)

Fully Active (3 Months)

Restricted Physical Strenuous Activity (3 Months)

Capable of Self Care Only (3 Months)

Capable of Limited Self Care Only (3 Months)

Completely Disabled (3 Months)

Fully Active (6 Months)

Restricted Physical Strenuous Activity (6 Months)

Capable of Self Care Only (6 Months)

Capable of Limited Self Care Only (6 Months)

Completely Disabled (6 Months)

Dead (6 Months)

Fully Active (9 Months)

Restricted Physical Strenuous Activity (9 Months)

Capable of Self Care Only (9 Months)

Capable of Limited Self Care Only (9 Months)

Completely Disabled (9 Months)

Dead (9 Months)

Fully Active (12 Months)

Restricted Physical Strenuous Activity (12 Months)

Capable of Self Care Only (12 Months)

Capable of Limited Self Care Only (12 Months)

Completely Disabled (12 Months)

Dead (12 Months)

FAS. ECOG performance status data was not reported for 24, 32, 96, 174, and 174 participants at baseline, 3, 6, 9, and 12 months, respectively.

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

Global Health Status/QoL (Baseline), (n=213)

Global Health Status/QoL (3 Months), (n=195)

Global Health Status/QoL (6 Months), (n=144)

Global Health Status/QoL (9 Months), (n=82)

Global Health Status/QoL (12 Month), (n=80)

Physical Functioning (Baseline), (n=212)

Physical Functioning (3 Months), (n=192)

Physical Functioning (6 Months), (n=144)

Physical Functioning (9 Months), (n=81)

Physical Functioning (12Months), (n=79)

Role Functioning (Baseline), (n=208)

Role Functioning (3 Months), (n=193)

Role Functioning (6 Months), (n=143)

Role Functioning (9 Months), (n=84)

Role Functioning (12Months), (n=80)

Emotional Functioning (Baseline), (n=215)

Emotional Functioning (3 Months), (n=194)

Emotional Functioning (6 Months), (n=144)

Emotional Functioning (9 Months), (n=84)

Emotional Functioning (12 Months), (n=80)

Cognitive Functioning (Baseline), (n=215)

Cognitive Functioning (3 Months), (n=193)

Cognitive Functioning (6 Months), (n=144)

Cognitive Functioning (9 Months), (n=84)

Cognitive Functioning (12 Months), (n=80)

Social Functioning (Baseline), (n=214)

Social Functioning (3 Months), (n=194)

Social Functioning (6 Months), (n=143)

Social Functioning (9 Months), (n=82)

Social Functioning (12 Months), (n=79)

Fatigue (Baseline), (n=214)

Fatigue (3 Months), (n=194)

Fatigue (6 Months), (n=144)

Fatigue (9 Months), (n=84)

Fatigue (12 Months), (n=80)

Nausea and Vomiting (Baseline), (n=214)

Nausea and Vomiting (3 Months), (n=194)

Nausea and Vomiting (6 Months), (n=144)

Nausea and Vomiting (9 Months), (n=84)

Nausea and Vomiting (12 Months), (n=80)

Pain (Baseline), (n=214)

Pain (3 Months), (n=193)

Pain (6 Months), (n=144)

Pain (9 Months), (n=84)

Pain (12 Months), (n=80)

Dyspnoea (Baseline), (n=214)

Dyspnoea (3 Months), (n=194)

Dyspnoea (6 Months), (n=144)

Dyspnoea (9 Months), (n=84)

Dyspnoea (12 Months), (n=80)

Insomnia (Baseline), (n=213)

Insomnia (3 Months), (n=192)

Insomnia (6 Months), (n=144)

Insomnia (9 Months), (n=84)

Insomnia (12 Months), (n=80)

Appetite Loss (Baseline), (n=214)

Appetite Loss (3 Months), (n=194)

Appetite Loss (6 Months), (n=144)

Appetite Loss (9 Months), (n=84)

Appetite Loss (12 Months), (n=80)

Constipation (Baseline), (n=214)

Constipation (3 Months), (n=194)

Constipation (6 Months), (n=144)

Constipation (9 Months), (n=83)

Constipation (12 Months), (n=80)

Diarrhoea (Baseline), (n=214)

Diarrhoea (3 Months), (n=194)

Diarrhoea (6 Months), (n=144)

Diarrhoea (9 Months), (n=84)

Diarrhoea (12 Months), (n=80)

Financial Difficulties (Baseline), (n=212)

Financial Difficulties (3 Months), (n=193)

Financial Difficulties (6 Months), (n=143)

Financial Difficulties (9 Months), (n=82)

Financial Difficulties (12 Months), (n=79)

FAS. n=number of participants with EORTC scale score data available at each specified time point

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma	NCT00460798	Renal Cell Carc...	Sutent: observa...	-	Pfizer
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma	NCT00460798	Renal Cell Carc...	Sutent: observa...	-	Pfizer

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