The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.
- 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
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 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 | Active, not recruiting | ||||
| Estimated Enrollment | 1 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2019 (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 | November 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
