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Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pierre Et Marie Curie Center
Algers, , 16005 Algeria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients being treated with SU as 1st line treatment according to the approved
therapeutic indication.

2. Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear
cell RCC) with measurable disease according to RECIST 1.1

3. Evidence of a personally signed and dated informed consent document indicating
that the patient (or a legally acceptable representative) has been informed of
all pertinent aspects of the study.

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

1. Patients being treated with cytokines or any other treatment other than SU in
1st line setting

2. Patients presenting with a known hypersensitivity to SU or its metabolites will
not be included in the study per the label.

NCT03140176
Pfizer
Not yet recruiting
Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.

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Descriptive Information
Brief TitleReal-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.
Official TitleREAL-WORLD CLINICAL PATTERNS OF CARE AND OUTCOMES AMONG PATIENTS IN AFRICA MIDDLE EAST (AFME) WITH METASTATIC RENAL CELL CARCINOMA (MRCC) RECEIVING SUNITINIB AS FIRST LINE THERAPY. PROSPECTIVE PRIMARY DATA COLLECTION STUDY
Brief SummaryOPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to efficacy outcomes, adverse events, and health related QoL in the real life setting.
Detailed Description

OPTIMISE study objectives are dual and aim primarily to increase the knowledge regarding the outcomes from Sunitinib use on one hand; and outcomes from the combined Sunitinib-2nd line sequence on the other hand in real life clinical practice.

This will be addressed in many countries across AfME and in individual country cohorts to understand specificities and differences in use and outcomes

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAdult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
ConditionMetastatic Renal Cell Carcinoma
InterventionDrug: Sunitinib
Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.
Other Name: Sutent
Study Groups/CohortsNot Provided
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 StatusRecruiting
Estimated Enrollment
 (submitted: May 2, 2017)
140
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 30, 2020
Estimated Primary Completion DateDecember 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • Inclusion Criteria:

    1. Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
    2. Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
    3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

      Exclusion Criteria:

    1. Patients being treated with cytokines or any other treatment other than SU in 1st line setting
    2. Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.
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 CountriesAlgeria,   Egypt
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03140176
Other Study ID NumbersA6181223
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:No
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 DateMarch 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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