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Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

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NCT04076787

Last updated on January 27, 2020
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Study Location
University of Calgary
Calgary, Alberta, P2N4N2 Canada
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Contact
1-800-718-1021
[email protected]
Related Links
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
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

NCT04076787
Pfizer
Completed
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

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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
  • Favorable IMDC risk group
    The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor
    Intervention: Drug: Sunitinib
  • Intermediate IMDC risk group
    The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as intermediate IMDC risk group for having 1 or 2 individual risk factors
    Intervention: Drug: Sunitinib
  • Poor IMDC risk group
    The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as poor IMDC risk group for having 3 or more individual risk factors
    Intervention: Drug: Sunitinib
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
 (submitted: August 30, 2019) 		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:

  • 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:

  • Initiated first line sunitinib treatment before 2010
  • Had non-clear cell mRCC
Sex/Gender
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Plan Description: Pfizer will provide access to related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

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