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Trial record 1 of 1 for:    NCT04175262
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Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175262
Recruitment Status : Completed
First Posted : November 25, 2019
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
IMDC group
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 21, 2019
First Posted Date November 25, 2019
Last Update Posted Date May 28, 2020
Actual Study Start Date October 31, 2019
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2019)
  • overall survival [ Time Frame: April 15th, 2014 to October 20th, 2019 ]
    retrospective cohort of patients
  • time to treatment discontinuation for 1st and 2nd line treatments [ Time Frame: April15th, 2014 to October 20th, 2019 ]
  • Reasons for treatment discontinuation [ Time Frame: April15th, 2014 to October 20th, 2019 ]
  • Physician-assessed best response [ Time Frame: April15th, 2014 to October 20th, 2019 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators IMDC group
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2020