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.
- 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
- Initiated first line sunitinib treatment before 2010
- Had non-clear cell mRCC
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 |
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| 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:
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| Sex/Gender |
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| 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 |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | September 2019 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
