Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02315755
Previous Study | Return to List | Next Study

Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Following TKIs In mRCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02315755
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Renal Cell Carcinoma
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Period Title: Overall Study
Started 102
Completed 102 [1]
Not Completed 0
[1]
Participants who died, were considered as 'completed'.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
Baseline analysis population included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
60  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
28
  27.5%
Male
74
  72.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.
Time Frame From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Data was not estimable due to less number of participants with events.
2.Primary Outcome
Title Percentage of Participants With Overall Objective Response
Hide Description Overall objective response was defined as the percentage of participants with best confirmed response (partial response [PR], stable disease [SD] or progressive disease [PD]) recorded from the start of the study treatment until the end of treatment as assessed by RECIST version 1.1. PR defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions. PD defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference to the smallest sum diameters while on study.
Time Frame Baseline until the maximum of 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
PR 23.5
SD 38.2
PD 18.6
3.Primary Outcome
Title Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline
Hide Description FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Time Frame Baseline (Day 1 of Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
26  (6)
4.Primary Outcome
Title Change From Baseline in FKSI-15 Score at Month 3
Hide Description FKSI was used to assess QoL of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Time Frame Baseline (Day 1 of Month 1), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (4.47)
5.Primary Outcome
Title Change From Baseline in FKSI-15 Score at Month 6
Hide Description FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Time Frame Baseline (Day 1 of Month 1), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.21  (4.22)
6.Primary Outcome
Title Change From Baseline in FKSI-15 Score at Month 9
Hide Description FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Time Frame Baseline (Day 1 of Month 1), Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.38  (4.56)
7.Primary Outcome
Title Change From Baseline in FKSI-15 Score at Last Follow-up
Hide Description FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Time Frame Baseline (Day 1 of Month 1), last follow-up visit (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (5.27)
8.Primary Outcome
Title EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best).
Time Frame Baseline (Day 1 of Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.522  (0.236)
9.Primary Outcome
Title Change From Baseline in EQ5D-3L Scores at Month 3
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Time Frame Baseline (Day 1 of Month 1), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.07  (0.17)
10.Primary Outcome
Title Change From Baseline in EQ5D-3L Score at Month 6
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Time Frame Baseline (Day 1 of Month 1), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.11  (0.34)
11.Primary Outcome
Title Change From Baseline in EQ5D-3L Score at Month 9
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Time Frame Baseline (Day 1 of Month 1), Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.06  (0.2)
12.Primary Outcome
Title Change From Baseline in EQ5D-3L Score at Last Follow-up
Hide Description EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Time Frame Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.05  (0.39)
13.Primary Outcome
Title Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline
Hide Description FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Time Frame Baseline (Day 1 of Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.56  (5.73)
14.Primary Outcome
Title Change From Baseline in FKSI-DRS Score at Month 3
Hide Description FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Time Frame Baseline (Day 1 of Month 1), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.13  (3.81)
15.Primary Outcome
Title Change From Baseline in FKSI-DRS Score at Month 6
Hide Description FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Time Frame Baseline (Day 1 of Month 1), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.04  (4.98)
16.Primary Outcome
Title Change From Baseline in FKSI-DRS Score at Month 9
Hide Description FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Time Frame Baseline (Day 1 of Month 1), Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.68  (4.94)
17.Primary Outcome
Title Change From Baseline in FKSI-DRS Score at Last Follow-up
Hide Description FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Time Frame Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (6.66)
18.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the start of 3rd line treatment until date of death due to any cause.
Time Frame From the start of 3rd line treatment until death due to any cause (up to a maximum of 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Median (Full Range)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Data was not estimable due to less number of participants with events.
19.Secondary Outcome
Title Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1
Hide Description Overall survival at Year 1 (Month 12) was defined as the time from the start of 3rd line treatment until death or 1 year due to any cause (measured at the end of 12 month follow-up/observation period). Percentage of participants who survived at the completion of 1 year (12 months) period were reported in this outcome measure.
Time Frame Baseline until death due to any cause (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
79.9
20.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was defined as the time from the start of treatment to the date of disease progression or date of permanent discontinuation. PD as per RECIST version 1.1 was defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%.
Time Frame Baseline until disease progression or discontinuation, due to any cause (up to 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 83
Median (Full Range)
Unit of Measure: months
4
(1 to 16)
21.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs were events which occurred between start of disease treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-SAE and SAEs.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
33
  32.4%
SAEs
5
   4.9%
22.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03
Hide Description An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. AEs included both SAEs and non-SAEs.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Count of Participants
Unit of Measure: Participants
13
  12.7%
23.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) During Third Line Targeted Treatment
Hide Description An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. Treatment emergent AEs during third line targeted treatment were events which occurred between first dose of third line targeted treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Count of Participants
Unit of Measure: Participants
6
   5.9%
24.Secondary Outcome
Title Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Hide Description Number of participants that required dose modifications of third line treatment due to AEs were reported in this outcome measure. Dose modification was categorized as escalation (increase in dose), delay or interruptions (change in dose time or skipping any dose), reduction (decrease in dose).
Time Frame Baseline up to Month 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants. Here, "Number analyzed, indicates participants evaluable for specified category".
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Count of Participants
Unit of Measure: Participants
Escalation: Month 3 Number Analyzed 82 participants
7
   8.5%
Interruption/delay: Month 3 Number Analyzed 82 participants
13
  15.9%
Reduction: Month 3 Number Analyzed 82 participants
4
   4.9%
None: Month 3 Number Analyzed 82 participants
58
  70.7%
Escalation: Month 6 Number Analyzed 57 participants
5
   8.8%
Interruption/delay: Month 6 Number Analyzed 57 participants
7
  12.3%
Reduction: Month 6 Number Analyzed 57 participants
2
   3.5%
None: Month 6 Number Analyzed 57 participants
43
  75.4%
Escalation: Month 9 Number Analyzed 38 participants
0
   0.0%
Interruption/delay: Month 9 Number Analyzed 38 participants
5
  13.2%
Reduction: Month 9 Number Analyzed 38 participants
0
   0.0%
None: Month 9 Number Analyzed 38 participants
33
  86.8%
Escalation: Month 12 Number Analyzed 29 participants
0
   0.0%
Interruption/delay: Month 12 Number Analyzed 29 participants
4
  13.8%
Reduction: Month 12 Number Analyzed 29 participants
0
   0.0%
None: Month 12 Number Analyzed 29 participants
25
  86.2%
25.Secondary Outcome
Title Correlation Coefficient Between Efficacy and Dose Modifications Due to AEs
Hide Description [Not Specified]
Time Frame Baseline up to Month 12 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Correlation coefficient
NA [1] 
[1]
Data was not estimable due to less number of participants with dose modifications due to AEs.
26.Secondary Outcome
Title Correlation Coefficient Between Efficacy and High Blood Pressure (>150 / 90 Millimeter of Mercury )
Hide Description [Not Specified]
Time Frame Baseline up to Month 12 follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all enrolled participants.
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description:
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Correlation coefficient
NA [1] 
[1]
Data was not estimable due to less number of participants with High blood pressure.
Time Frame Baseline up to 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metastatic Renal Cell Carcinoma (mRCC) Cohort
Hide Arm/Group Description Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
All-Cause Mortality
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Affected / at Risk (%)
Total   35/102 (34.31%) 
Hide Serious Adverse Events
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Affected / at Risk (%)
Total   5/102 (4.90%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/102 (0.98%) 
General disorders   
Mass in right on brochis * 2 [1]  1/102 (0.98%) 
Infections and infestations   
Pneumonia * 1  1/102 (0.98%) 
Investigations   
Blood creatinine increased * 1  1/102 (0.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastasis * 1  1/102 (0.98%) 
1
Term from vocabulary, medDRA v21.1
2
Term from vocabulary, No Vocabulary
*
Indicates events were collected by non-systematic assessment
[1]
No vocabulary was used for this term and event.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Affected / at Risk (%)
Total   33/102 (32.35%) 
Cardiac disorders   
Angina pectoris * 1  1/102 (0.98%) 
Palpitations * 1  1/102 (0.98%) 
Endocrine disorders   
Hypogonadism * 1  1/102 (0.98%) 
Hypothyroidism * 1  2/102 (1.96%) 
Gastrointestinal disorders   
Diarrhoea * 1  8/102 (7.84%) 
Nausea * 1  3/102 (2.94%) 
Oral pain * 1  3/102 (2.94%) 
Vomiting * 1  2/102 (1.96%) 
Stomatitis * 1  2/102 (1.96%) 
Abdominal pain * 1  1/102 (0.98%) 
General disorders   
Asthenia * 1  8/102 (7.84%) 
Chills * 1  1/102 (0.98%) 
Fatigue * 1  1/102 (0.98%) 
Mucosal inflammation * 1  1/102 (0.98%) 
Pyrexia * 1  1/102 (0.98%) 
Swelling * 1  1/102 (0.98%) 
Cotton in mouth * 2 [1]  1/102 (0.98%) 
Inappetency * 2 [1]  2/102 (1.96%) 
Infections and infestations   
Acute sinusitis * 1  1/102 (0.98%) 
Bronchitis * 1  1/102 (0.98%) 
Conjunctivitis * 1  1/102 (0.98%) 
Upper respiratory tract infection * 1  1/102 (0.98%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/102 (0.98%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  1/102 (0.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastasis * 1  1/102 (0.98%) 
Psychiatric disorders   
Insomnia * 1  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/102 (2.94%) 
Dyspnoea * 1  1/102 (0.98%) 
Pneumonitis * 1  1/102 (0.98%) 
Productive cough * 1  1/102 (0.98%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  1/102 (0.98%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  1/102 (0.98%) 
Rash * 1  1/102 (0.98%) 
Vascular disorders   
Hypertension * 1  5/102 (4.90%) 
Deep vein thrombosis * 1  2/102 (1.96%) 
1
Term from vocabulary, medDRA v21.1
2
Term from vocabulary, No vocabulary.
*
Indicates events were collected by non-systematic assessment
[1]
No vocabulary was used for this term and event.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02315755    
Other Study ID Numbers: A4061086
First Submitted: December 9, 2014
First Posted: December 12, 2014
Results First Submitted: November 14, 2018
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019