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).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 77
- 试验地点
- 8
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
- •Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
- •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.
排除标准
- •Patients being treated with cytokines or any other treatment other than SU in 1st line setting
- •Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 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)
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.
Time to Treatment Failure (TTF)
时间窗: From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)
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.
次要结局
- 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))
- Time to First Interruption(During treatment period (up to 12 months))
- Time to All Interruptions(During treatment period (up to 12 months))
- 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))
- Combined Progression Free Survival(From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months))
- Objective Response Rate (ORR) at Months 3, 6, 9 and 12(Months 3, 6, 9 and 12)
- Number of Participants With Recommended Starting Dose of Sunitinib(At initiation of sunitinib (Day 0))
- Number of Participants With Other Starting Doses(At initiation of sunitinib (Day 0))
- Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose(At initiation of sunitinib (Day 0))
- Average Dose Received Over the Sunitinib Treatment Period(During treatment period (up to 12 months))
- Dose Intensity of Sunitinib(During treatment period (up to 12 months))
- Number of Participants With Change in Dose or Schedule of Sunitinib(Month 3, 6, 9 and 12)
- Number of Participants With Dose Increase(During treatment period (up to 12 months))
- Number of Participants With Temporary Interruption During the Sunitinib Treatment Period(During treatment period (up to 12 months))
- Number of Participants According to Reasons for Temporary Interruption(Months 3, 6, 9 and 12)
- Number of Participants With Sunitinib Discontinuation(Months 3, 6, 9 and 12)
- Number of Participants According to Reasons for Sunitinib Discontinuation(Months 3, 6, 9 and 12)
- Median Duration of 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))
- Combined TTF for the Sunitinib-2nd Line Sequence(From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months))
- Combined PFS According to Type of Second Line Treatment(From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months))
- Overall Survival(From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months))
- Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Number of Most Common AEs of Any Grade by Preferred Term(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Number of Events of Diarrhea, Hypertension, Fatigue, Asthenia, Palmar-plantar Erythrodysesthesia Syndrome, Nausea, Stomatitis, Neutropenia, Lymphopenia and Elevated Lipase(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Number of Participants With Serious Adverse Events and Non-Serious AEs(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Number of Participants Who Discontinued Treatment Due to AEs(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Duration of Treatment Until Discontinuation for AEs(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Number of Adverse Events According to Grade(From date of sunitinib first dose until end of follow-up (up to maximum of 36 months))
- Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores(Day 0, Month 3, 6, 9, 12, 18 and 24)
- Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores(Day 0, Month 3, 6, 9, 12, 18 and 24)