Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.
NCT03140176
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Adult Trials: 18+ Years
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.
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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy. | ||||||
| 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). | ||||||
| Brief Summary | 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. | ||||||
| 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 Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy. | ||||||
| Condition | Metastatic Renal Cell Carcinoma | ||||||
| Intervention | 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 | ||||||
| Study Groups/Cohorts | Not 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 Status | Recruiting | ||||||
| Estimated Enrollment | 140 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | January 1, 2021 | ||||||
| Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Algeria, Egypt | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03140176 | ||||||
| Other Study ID Numbers | A6181223 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Pfizer | ||||||
| Verification Date | May 2020 | ||||||