Clinical trial NCT03140176: 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).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Sunitinib
Metastatic Renal Cell Carcinoma
Africa Middle East
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.

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

Eligibility 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:

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  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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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)
measure: Time to Treatment Failure (TTF)
timeFrame: From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) at Months 3, 6, 9 and 12
timeFrame: Months 3, 6, 9 and 12
measure: Number of Participants With Recommended Starting Dose of Sunitinib
timeFrame: At initiation of sunitinib (Day 0)
measure: Number of Participants With Other Starting Doses
timeFrame: At initiation of sunitinib (Day 0)
measure: Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose
timeFrame: At initiation of sunitinib (Day 0)
measure: Average Dose Received Over the Sunitinib Treatment Period
timeFrame: During treatment period (up to 12 months)
measure: Dose Intensity of Sunitinib
timeFrame: During treatment period (up to 12 months)
measure: Number of Participants With Change in Dose or Schedule of Sunitinib
timeFrame: Month 3, 6, 9 and 12
measure: Number of Participants With Dose Increase
timeFrame: During treatment period (up to 12 months)
measure: Number of Participants With Temporary Interruption During the Sunitinib Treatment Period
timeFrame: During treatment period (up to 12 months)
measure: Time to First Interruption
timeFrame: During treatment period (up to 12 months)
measure: Time to All Interruptions
timeFrame: During treatment period (up to 12 months)
measure: Number of Participants According to Reasons for Temporary Interruption
timeFrame: Months 3, 6, 9 and 12
measure: Number of Participants With Sunitinib Discontinuation
timeFrame: Months 3, 6, 9 and 12
measure: Number of Participants According to Reasons for Sunitinib Discontinuation
timeFrame: Months 3, 6, 9 and 12
measure: Median Duration of Sunitinib Treatment
timeFrame: From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months)
measure: Combined Progression Free Survival
timeFrame: From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
measure: Combined TTF for the Sunitinib-2nd Line Sequence
timeFrame: From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months)
measure: Combined PFS According to Type of Second Line Treatment
timeFrame: From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
measure: Overall Survival
timeFrame: From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months)
measure: Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Most Common AEs of Any Grade by Preferred Term
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Participants With Serious Adverse Events and Non-Serious AEs
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Adverse Events According to Grade
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Participants Who Discontinued Treatment Due to AEs
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Duration of Treatment Until Discontinuation for AEs
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Participants Who Died Due to Any Cause
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Number of Participants According to the Cause of Death
timeFrame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores
timeFrame: Day 0, Month 3, 6, 9, 12, 18 and 24
measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores
timeFrame: Day 0, Month 3, 6, 9, 12, 18 and 24
Other outcomes:
Locations:
city: Algers
country: Algeria
facility: Pierre Et Marie Curie Center
city: Annaba
country: Algeria
facility: CAC Annaba
city: Annaba
country: Algeria
facility: Hanene Djedi
city: Cairo
country: Egypt
facility: Kasr Al Aini
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Cairo
country: Egypt
facility: Demerdash Hospital
city: Kuwait City
country: Kuwait
facility: Kuwait Cancer Control Center
city: Rabat
country: Morocco
facility: Institut National D'Oncologie
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: