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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)

Last updated on October 14, 2019

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Study Location
Pfizer
Buenos Aires, , C1426ANZ Argentina
Contact
1-800-718-1021
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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)

NCT04115189
Pfizer
Not yet recruiting
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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Descriptive Information
Brief TitleA Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)
Official TitleA Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America
Brief SummaryTo 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
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

Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2014-2018
ConditionMetastatic Renal Cell Carcinoma ( mRCC)
InterventionDrug: Sunitinib
Patients to receive Sunitinib as first line therapy for mRCC
Study Groups/CohortsPatients 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
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 StatusNot yet recruiting
Estimated Enrollment
 (submitted: October 2, 2019)
150
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 1, 2019
Estimated Primary Completion DateDecember 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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)

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesArgentina
Removed Location Countries  
 
Administrative Information
NCT NumberNCT04115189
Other Study ID NumbersA6181231
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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