Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy. (OPTIMISE)
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|ClinicalTrials.gov Identifier: NCT03140176|
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : July 28, 2021
|Condition or disease||Intervention/treatment|
|Metastatic Renal Cell Carcinoma||Drug: Sunitinib|
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 Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||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 (OPTIMISE).|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
- 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
- Progression-Free Survival (PFS) From Initiation of Sunitinib Therapy [ Time Frame: From initiation of treatment up to 36 months ]PFS was defined as the time from initiation of sunitinib therapy to first documentation of tumor progression or to death due to any cause, whichever occurred first.
- Time to Failure (TTF) [ Time Frame: From start of study treatment through 36 months ]TTF is defined as the time from the date of first dose of study treatment (Sunitinib) to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason (unless due to good outcome).
- Objective Response Rate - Percentage of Participants With Objective Response (ORR) [ Time Frame: From 1st dosing up to 36 months ]Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease.
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): NCT03140176
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Pierre Et Marie Curie Center||Recruiting|
|Algers, Algeria, 16005|
|Kasr Al Aini||Recruiting|
|Cairo, Egypt, 11562|
|National Cancer Institute||Recruiting|
|Cairo, Egypt, 11796|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|