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: December 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: 77
• 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)	PFS was defined as the time from when the participant received the first dose of sunitinib to the time of progression or death due to any cause, which occurred first. The time of progression was the date of the first tumor assessment where the progression was notified as response to therapy, over the sunitinib treatment. Participants who discontinued the study for any reason, including unacceptable toxicity during the treatment period, who remained alive and without disease progression, were censored at the last disease assessment that verified lack of disease progression. As per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.	From date of first dose of sunitinib to date of progression or death or censored date, whichever occurred first (up to maximum of 36 months)
Primary	Time to Treatment Failure (TTF)	TTF was defined as the time from when the participant received the first dose of sunitinib to the time of sunitinib discontinuation (date completed by the physician). In case of death when the participant was still treated with sunitinib, date of death was considered as date of discontinuation. If no sunitinib discontinuation was reported during the follow-up visits, participants were censored to the last follow-up visit.	From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)
Secondary	Objective Response Rate (ORR) at Months 3, 6, 9 and 12	ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.	Months 3, 6, 9 and 12
Secondary	Number of Participants With Recommended Starting Dose of Sunitinib	The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off.	At initiation of sunitinib (Day 0)
Secondary	Number of Participants With Other Starting Doses	Number of participants with other starting doses of sunitinib (50 mg per day, 2 weeks on, 1 week off; 37.5 mg per day for 2 weeks on and 1 week off; 25 mg per day for 2 weeks on and 1 week off; 37.5 mg per day 4 weeks on and 2 weeks off) were reported in this outcome measure.	At initiation of sunitinib (Day 0)
Secondary	Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose		At initiation of sunitinib (Day 0)
Secondary	Average Dose Received Over the Sunitinib Treatment Period		During treatment period (up to 12 months)
Secondary	Dose Intensity of Sunitinib	Dose intensity was defined as defined as the sum of sunitinib daily doses divided by the duration of sunitinib treatment in days (delay between the first sunitinib dose and the last dose, including temporary interruption).	During treatment period (up to 12 months)
Secondary	Number of Participants With Change in Dose or Schedule of Sunitinib	Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure.	Month 3, 6, 9 and 12
Secondary	Number of Participants With Dose Increase		During treatment period (up to 12 months)
Secondary	Number of Participants With Temporary Interruption During the Sunitinib Treatment Period		During treatment period (up to 12 months)
Secondary	Time to First Interruption		During treatment period (up to 12 months)
Secondary	Time to All Interruptions		During treatment period (up to 12 months)
Secondary	Number of Participants According to Reasons for Temporary Interruption	Number of participants according to reasons for temporary interruption (adverse events, logistical, personal and intolerant to sunitinib) at specified time points is presented in this outcome measure.	Months 3, 6, 9 and 12
Secondary	Number of Participants With Sunitinib Discontinuation	Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.	Months 3, 6, 9 and 12
Secondary	Number of Participants According to Reasons for Sunitinib Discontinuation	Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure.	Months 3, 6, 9 and 12
Secondary	Median Duration of Sunitinib Treatment	Median duration of treatment was defined as the time between the sunitinib initiation and the sunitinib discontinuation date or the last follow-up date with sunitinib treatment.	From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months)
Secondary	Combined Progression Free Survival	Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.	From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
Secondary	Combined TTF for the Sunitinib-2nd Line Sequence	Combined TTF was defined as the time from when the participant received the first dose with sunitinib as first line, to the time of 2nd line sequence discontinuation (date completed by the physician).	From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months)
Secondary	Combined PFS According to Type of Second Line Treatment	Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. Combined PFS according to the type of second line treatment (best supportive care [BSC], tyrosine kinase inhibitors [TKI] including pazopanib and mammalian target of rapamycin [mTOR] inhibitors including everolimus) were reported in this outcome measure.	From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
Secondary	Overall Survival	Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.	From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months)
Secondary	Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade	An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of participants with at least one AE of any grade is reported.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Most Common AEs of Any Grade by Preferred Term	An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to NCI-CTCAE as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of most common AEs of any grade is presented. Only events captured as deaths (preferred term) are reported as deaths in the data table.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase	Number of events of diarrhea, hypertension, fatigue, asthenia, palmar-plantar erythrodysesthesia syndrome, nausea, stomatitis, neutropenia, lymphopenia and elevated lipase were reported in this outcome measure.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Participants With Serious Adverse Events and Non-Serious AEs	A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. In this outcome measure, number of participants with serious adverse events and non-serious adverse events are reported.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Adverse Events According to Grade	An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Participants Who Discontinued Treatment Due to AEs	An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. In this outcome measure, number of participants who discontinued treatment due to AEs are reported.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Duration of Treatment Until Discontinuation for AEs	An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Participants Who Died Due to Any Cause		From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Number of Participants According to the Cause of Death		From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Secondary	Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores	The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-Disease Related Symptoms [DRS]-Physical [P]-12 items, FKSI-DRS-Emotional [E]-1 item, treatment side effects [TSE]-3 items, functional wellbeing [FWB]-3 items). Participants were required to respond to a total of 19 questions regarding symptoms, side effects and wellbeing on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total FKSI scores were calculated as the sum of the item responses divided by the number of items completed multiplied by the total number of items in the scale and ranged from 0 (severely symptomatic) to 76 (asymptomatic), where higher scores indicated better health.	Day 0, Month 3, 6, 9, 12, 18 and 24
Secondary	Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores	The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-DRS-P: 12 items, FKSI-DRS-E: 1 item, TSE: 3 items, FWB: 3 items). Participants were required to respond to the items in each subscale on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The FKSI subscale scores were calculated as the sum of item responses divided by the number of items completed multiplied by the total number of items in the subscale and ranged from 0 (severely symptomatic) to 48 (asymptomatic) for FKSI-DRS-P, 0 (severely symptomatic) to 4 (asymptomatic) for FKSI-DRS-E and 0 (severely symptomatic) to 12 (asymptomatic) for TSE and FWB; higher scores indicated better health.	Day 0, Month 3, 6, 9, 12, 18 and 24

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