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Trial record 1 of 1 for:    NCT04076787
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Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

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ClinicalTrials.gov Identifier: NCT04076787
Recruitment Status : Completed
First Posted : September 3, 2019
Results First Posted : October 10, 2019
Last Update Posted : February 23, 2021
Sponsor:
Collaborators:
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Analysis Group
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 30, 2019
First Posted Date September 3, 2019
Results First Submitted Date September 16, 2019
Results First Posted Date October 10, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date September 1, 2018
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2019)
  • Overall Survival [ Time Frame: 60 months ]
    Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
  • Time to First-Line Sunitinib Treatment Discontinuation [ Time Frame: 60 months ]
    Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
  • Number of Participants Who Discontinued First-Line Sunitinib Treatment [ Time Frame: 60 months ]
    In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported.
  • Percentage of Participants With Objective Response (OR) [ Time Frame: 60 months ]
    Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.
  • Percentage of Participants With Progressive Disease [ Time Frame: 60 months ]
    Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
  • Percentage of Participants With Stable Disease [ Time Frame: 60 months ]
    Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.
Original Primary Outcome Measures
 (submitted: August 30, 2019)
Overall Survival [ Time Frame: January 1, 2010 to March 29, 2018 ]
Retrospective Cohort of patients from 2010 to 2018
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: August 30, 2019)
  • Physician-assessed best response [ Time Frame: January 1, 2010 to March 29, 2018 ]
    Physician-assessed best response according to objective response rate
  • Treatment discontinuation [ Time Frame: January 1, 2010 to March 29, 2018 ]
    The time from sunitinib initiation to discontinuation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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/data_requests
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
  • Analysis Group
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021