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

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NCT03140176

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Centre AntiCancer d'Annaba
Souk-Ahras, Annaba, 41000 Algeria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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+ 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
Recruiting
Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.

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[email protected]

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

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.
Other Name: Sutent
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 30, 2020
December 30, 2020   (Final data collection date for primary outcome measure)

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Algeria
 
 
NCT03140176
A6181223
No
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
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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