Renal Cell CarcinomaSUNIKANCT00460798

SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

An observational study of Renal Cell Carcinoma, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Renal Cell Carcinoma
What is being tested?: Sutent: observational study
How many people: 356 participants
Where: No sites listed yet
Study dates: Feb 2007to Sep 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists

Who may be able to join

First-line treatment in patients with metastatic renal cell carcinoma

Who cannot join

Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

About this study

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

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.

Read the detailed description

The Statistical Analysis Plan provides detailed specification of the analysis

Conditions: Renal Cell Carcinoma
Being tested: Sutent: observational study
Keywords: Sunitinib, kidney diseases, urogenital neoplasms, kidney cancer
Medical subject headings: Carcinoma, Renal Cell, Kidney Diseases, Urogenital Neoplasms, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sutent: observational studyOther
Also called sunitinib malate
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Study groups in NCT00460798
Study group	Role	What they receive
Non-Interventional Study		Not described Receives: Other: Sutent: observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Categorical Best Overall Response
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.
Measured: Start of Treatment up through 12 Months or Early Discontinuation
Number of Participants With Objective Response
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.
Measured: 12 Months or Early Discontinuation
Time to Progression (TTP)
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.
Measured: Start of Treatment up through 12 Months or Early Discontinuation
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
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
Measured: Baseline, 3, 6, 9 and 12 Months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
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
Measured: Baseline, 3, 6, 9 and 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Sep 2009

First posted16 Apr 2007 (estimated)
Study startFeb 2007
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00460798
Sponsor's protocol ID: A6181115
Acronym: SUNIKA
Status last verified: Nov 2010
First submitted: 13 Apr 2007
Last updated: 16 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
ClinicalTrials.gov ID: NCT00460798
Acronym / sponsor ID: SUNIKA / A6181115
Conditions: Renal Cell Carcinoma
Keywords: Sunitinib, kidney diseases, urogenital neoplasms, kidney cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 16 Apr 2007 (estimated)
Results: Posted 4 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

1 year.

Detailed description

The Statistical Analysis Plan provides detailed specification of the analysis

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Non-Interventional Study	–	Other: Sutent: observational study

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists

Key inclusion criteria (1 listed)

First-line treatment in patients with metastatic renal cell carcinoma

Key exclusion criteria (1 listed)

Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sutent: observational studyAlso: sunitinib malateSUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma	Other	Non-Interventional Study

Primary outcome

Number of Participants With Categorical Best Overall Response
Time frame: Start of Treatment up through 12 Months or Early Discontinuation
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.
Number of Participants With Objective Response
Time frame: 12 Months or Early Discontinuation
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.
Time to Progression (TTP)
Time frame: Start of Treatment up through 12 Months or Early Discontinuation
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.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline, 3, 6, 9 and 12 Months
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
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
Time frame: Baseline, 3, 6, 9 and 12 Months
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

Results and safety

Results posted to the registry on 4 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib	448	108

Primary outcome: Number of Participants With Categorical Best Overall Response

Time frame: Start of Treatment up through 12 Months or Early Discontinuation. Number. Unit: Participants

Measure	Sunitinib n = 352
Complete Response (CR)	13
Partial Response (PR)	130
Stable Disease/No Response	120
Progressive Disease (PD)	58
Indeterminate	31

Sunitinib: Obective Response Rate (Percent): 40.6 (95% CI 35.5 to 46.0)

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

Primary outcome: Number of Participants With Objective Response

Time frame: 12 Months or Early Discontinuation. Number. Unit: Participants

Measure	Sunitinib n = 352
Value	77

Population analysed: FAS

Primary outcome: Time to Progression (TTP)

Time frame: Start of Treatment up through 12 Months or Early Discontinuation. Median (95% Confidence Interval). Unit: Months

Measure	Sunitinib n = 352
Value	12.0 (10.3 to 13.5)

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

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

Time frame: Baseline, 3, 6, 9 and 12 Months. Number. Unit: Participants

Measure	Sunitinib n = 352
Fully Active (Baseline)	84
Restricted Physical Strenuous Activity (Baseline)	179
Capable of Self Care Only (Baseline)	58
Capable of Limited Self Care Only (Baseline)	6
Completely Disabled (Baseline)	1
Fully Active (3 Months)	57
Restricted Physical Strenuous Activity (3 Months)	169
Capable of Self Care Only (3 Months)	78

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib	100 of 421 (23.8%)	232 of 421 (55.1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Categorical Best Overall Response (time frame: Start of Treatment up through 12 Months or Early Discontinuation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00460798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.