Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments

NCT04175262

Last updated date
Study Location
University of Calgary
Calgary, Alberta, p2n 4n2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma (mRCC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


None

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ALL GENDERS
18 Years+
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MULTIPLE SITES
Metastatic Renal Cell Carcinoma (mRCC)Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
NCT04175262
  1. Calgary, Alberta
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
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 Completed
Actual Enrollment
 (submitted: May 1, 2020)
102
Original Estimated Enrollment
 (submitted: November 22, 2019)
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:

  • 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)

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study:All
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and 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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators IMDC group
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020