Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
NCT04175262
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- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Diagnosed with mRCC
- Received IO therapy as 1L therapy
- Received sunitinib as 2L therapy
- Age 18 years or over at the time of mRCC diagnosis
- Actively treated at an IMDC clinical center (to avoid incomplete data)
None
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Descriptive Information | |||||
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Brief Title | Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments | ||||
Official Title | Clinical Effectiveness of Second-Line Sunitinib Following Immune-oncologic (IO) Therapy in Patients With Metastatic Renal Cell Carcinoma in the International Metastatic Renal Cell Carcinoma Database (IMDC) | ||||
Brief Summary | The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices. | ||||
Detailed Description | Not Provided | ||||
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 with diagnosis of mRCC who initiated sunitinib as 2nd line treatment | ||||
Condition | Metastatic Renal Cell Carcinoma (mRCC) | ||||
Intervention | Drug: sunitinib
Patients to receive sunitinib as second line therapy for mRCC | ||||
Study Groups/Cohorts | Patients with mRCC
Patients diagnosed with metastatic RCC receiving first line (1L) combination of IOs therapies followed by Sunitinib as a second line (2L) treatment 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 | 102 | ||||
Original Estimated Enrollment | 1 | ||||
Actual Study Completion Date | March 9, 2020 | ||||
Actual Primary Completion Date | March 9, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: None | ||||
Sex/Gender |
| ||||
Ages | Child, 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 | NCT04175262 | ||||
Other Study ID Numbers | A6181233 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | IMDC group | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | May 2020 |