OPTIMISE: Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) From Initiation of Sunitinib Therapy [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) [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).
Secondary Outcome Measures
- Objective Response Rate - Percentage of Participants With Objective Response (ORR) [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.
Eligibility Criteria
Criteria
- Inclusion Criteria:
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Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
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Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
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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:
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Patients being treated with cytokines or any other treatment other than SU in 1st line setting
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Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pierre Et Marie Curie Center | Algers | Algeria | 16005 | |
| 2 | CAC Annaba | Annaba | Algeria | ||
| 3 | Hanene Djedi | Annaba | Algeria | ||
| 4 | Kasr Al Aini | Cairo | Egypt | 11562 | |
| 5 | National Cancer Institute | Cairo | Egypt | 11796 | |
| 6 | Demerdash Hospital | Cairo | Egypt |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A6181223