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A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)

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ClinicalTrials.gov Identifier: NCT04115189
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To describe real-world demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients in Latin America who were treated with first-line sunitinib for metastatic renal cell carcinoma and switched from the 4/2 to 2/1 administration schedule

Condition or disease Intervention/treatment
Metastatic Renal Cell Carcinoma ( mRCC) Drug: Sunitinib

Detailed Description:

Understanding characteristics of patients who switched from a 4/2 to a 2/1 sunitinib schedule or initiated the 2/1 schedule in Brazil, and the resulting clinical outcomes in the real-world setting

• Describing the occurrence of AEs on the 4/2 and 2/1 schedules


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America
Estimated Study Start Date : October 7, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Metastatic RCC
Patients diagnosed with metastatic RCC with clear cell histology who switched from a 4/2 schedule to a 2/1 schedule of sunitinib in first-line metastatic treatment between January 1, 2014 and June 30, 2018
Drug: Sunitinib
Patients to receive Sunitinib as first line therapy for mRCC




Primary Outcome Measures :
  1. Response Duration on Sunitinib 2/1 schedule [ Time Frame: From January 1 2014 to June 30 2018 ]
    A Retrospective Medical Record Review


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: January 1 to June 30 2018 ]
    Explore clinical outcome switching to the 2/1 schedule


Other Outcome Measures:
  1. Adverse Events [ Time Frame: From January 1 to June 30 2018 ]
    The protocol will collect all treatment related adverse events under Sunitinib treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2014-2018
Criteria

Inclusion Criteria:

  1. Diagnosed with metastatic RCC with clear cell histology

    a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease)

  2. Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only)
  3. Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements

Exclusion Criteria:

1. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115189


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Argentina
Pfizer Not yet recruiting
Buenos Aires, Argentina, C1426ANZ
Contact       ceiaf@alexanderfleming.org   
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04115189     History of Changes
Other Study ID Numbers: A6181231
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (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.
Keywords provided by Pfizer:
Sunitinib -
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action