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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Metastatic Renal Cell Carcinoma Drug: Sunitinib

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

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Algeria
Pierre Et Marie Curie Center Recruiting
Algers, Algeria, 16005
CAC Annaba Recruiting
Annaba, Algeria
Hanene Djedi Recruiting
Annaba, Algeria
Egypt
Kasr Al Aini Recruiting
Cairo, Egypt, 11562
National Cancer Institute Recruiting
Cairo, Egypt, 11796
Demerdash Hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03140176    
Other Study ID Numbers: A6181223
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (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/data_requests.

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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
Keywords provided by Pfizer:
Sunitinib
Metastatic Renal Cell Carcinoma
Africa Middle East
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action