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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 2, 2019
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Metastatic Renal Cell Carcinoma Drug: Sunitinib

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.

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Study Type : Observational
Actual Enrollment : 1769 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : September 2, 2018
Actual Study Completion Date : September 2, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC

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
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC

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
Drug: Sunitinib
patients who received sunitinib as first line therapy for mRCC




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076787


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, P2N4N2
Sponsors and Collaborators
Pfizer
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04076787     History of Changes
Other Study ID Numbers: A6181229
First Posted: September 2, 2019    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: September 2019
Individual Participant Data (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
Keywords provided by Pfizer:
Vascular endothelial growth factor (VEGF)
Sunitinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Endothelial Growth Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors