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

Metastatic Renal Cell Carcinoma Clinical Trial

— OPTIMISE  

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03140176
• Other study ID #: A6181223
• Status: Terminated
• Start date: August 15, 2017
• Est. completion date: January 22, 2022

Study information

• Verified date: January 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: January 22, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• 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.

Locations

Country	Name	City	State
Algeria	Pierre Et Marie Curie Center	Algers
Algeria	CAC Annaba	Annaba
Algeria	Hanene Djedi	Annaba
Egypt	Demerdash Hospital	Cairo
Egypt	Kasr Al Aini	Cairo
Egypt	National Cancer Institute	Cairo
Kuwait	Kuwait Cancer Control Center	Kuwait City
Morocco	Institut National D'Oncologie	Rabat

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Algeria,  Egypt,  Kuwait,  Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) From Initiation of Sunitinib Therapy	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.	From initiation of treatment up to 36 months
Primary	Time to Failure (TTF)	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).	From start of study treatment through 36 months
Secondary	Objective Response Rate - Percentage of Participants With Objective Response (ORR)	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.	From 1st dosing up to 36 months

External Links

•   To obtain contact information for a study center near you, click here.