Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
NCT04076787
Last updated date
ABOUT THIS STUDY
This is a retrospective, longitudinal cohort study that assessed clinical outcomes of
patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line
treatment.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosed with mRCC
- Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy
- Age 18 years or over at the time of mRCC diagnosis
- Actively treated at an IMDC clinical center
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Initiated first line sunitinib treatment before 2010
- Had non-clear cell mRCC
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Metastatic Renal Cell CarcinomaBiological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma
NCT00930345
- Paris,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Metastatic Renal Cell CarcinomaClinical Trial to Assess the Importance of Nephrectomy
NCT00930033
- Paris,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Metastatic Renal Cell CarcinomaPost Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
NCT01073644
- Cebu City,
- Manila,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Metastatic Renal Cell CarcinomaCost Effectiveness Of Sunitinib In Central America And Caribbean
NCT01033981
- Panama City,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib | ||||
| Official Title | The Effect of Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) on Clinical Outcomes Among Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received First-Line Sunitinib in the International mRCC Database Consortium (IMDC) Based on Prognostic Risk Score | ||||
| Brief Summary | This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment. | ||||
| Detailed Description | Clear cell mRCC patients who initiated sunitinib as first-line treatment between 2010 and 2018 were identified from the IMDC database. Patients were classified as favorable, intermediate, or poor prognostic risk group according to IMDC criteria. Overall survival, time to treatment discontinuation, and physician-assessed tumor response were evaluated. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2010 and 2018 | ||||
| Condition | Metastatic Renal Cell Carcinoma | ||||
| Intervention | Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC | ||||
| Study Groups/Cohorts |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment | 1769 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | September 2, 2018 | ||||
| Actual Primary Completion Date | September 2, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04076787 | ||||
| Other Study ID Numbers | A6181229 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | September 2019 | ||||