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Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients (NIMES-ROC)

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: NCT02825420
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : October 29, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Relapsed Ovarian Cancer
Intervention Drug: trabectedin
Enrollment 220
Recruitment Details A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit.
Pre-assignment Details  
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Hide Arm/Group Description Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Period Title: Overall Study
Started 131 89
Completed 88 72
Not Completed 43 17
Reason Not Completed
Death             30             12
Progressive disease             6             1
Lost to Follow-up             2             2
Withdrawal by Subject             1             1
Protocol amendment not signed             1             1
Physician Decision             1             0
Did not receive PLD             2             0
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics Total
Hide Arm/Group Description Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib Total of all reporting groups
Overall Number of Baseline Participants 129 89 218
Hide Baseline Analysis Population Description
2 patients enrolled did not receive PLD
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
  58.1%
54
  60.7%
129
  59.2%
>=65 years
54
  41.9%
35
  39.3%
89
  40.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 129 participants 89 participants 218 participants
61.0
(39 to 82)
61.0
(40 to 86)
61.0
(39 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
Female
129
 100.0%
89
 100.0%
218
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Belgium Number Analyzed 129 participants 89 participants 218 participants
10
   7.8%
2
   2.2%
12
   5.5%
Italy Number Analyzed 129 participants 89 participants 218 participants
57
  44.2%
37
  41.6%
94
  43.1%
France Number Analyzed 129 participants 89 participants 218 participants
9
   7.0%
5
   5.6%
14
   6.4%
Germany Number Analyzed 129 participants 89 participants 218 participants
16
  12.4%
2
   2.2%
18
   8.3%
Spain Number Analyzed 129 participants 89 participants 218 participants
39
  30.2%
43
  48.3%
82
  37.6%
Weight   [1] 
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 116 participants 83 participants 199 participants
64.0
(40.0 to 130.0)
68.0
(43.0 to 109.0)
65.0
(40.0 to 130.0)
[1]
Measure Analysis Population Description: 19 patients not evaluated
Height   [1] 
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 116 participants 83 participants 199 participants
160
(146 to 178)
158
(144 to 173)
160
(144 to 178)
[1]
Measure Analysis Population Description: 19 patients not evaluated
Calculated body surface area   [1] 
Median (Full Range)
Unit of measure:  M^2
Number Analyzed 113 participants 81 participants 194 participants
1.7
(1.3 to 2.4)
1.7
(1.4 to 2.2)
1.7
(1.3 to 2.4)
[1]
Measure Analysis Population Description: 24 patients not evaluated
Investigator reported body surface area   [1] 
Median (Full Range)
Unit of measure:  M^2
Number Analyzed 113 participants 81 participants 194 participants
1.6
(1.3 to 2.2)
1.7
(1.4 to 2.1)
1.7
(1.3 to 2.2)
[1]
Measure Analysis Population Description: 24 patients not evaluated
Tumor grade at diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
High grade
95
  73.6%
61
  68.5%
156
  71.6%
Intermediate grade
9
   7.0%
5
   5.6%
14
   6.4%
Low grade
6
   4.7%
6
   6.7%
12
   5.5%
Not done/not reported/unknown
19
  14.7%
17
  19.1%
36
  16.5%
Histopathology at initial ovarian cancer diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
Papillary/serous
97
  75.2%
60
  67.4%
157
  72.0%
Endometroid
6
   4.7%
8
   9.0%
14
   6.4%
Clear cell carcinoma
6
   4.7%
4
   4.5%
10
   4.6%
Peritoneal carcinoma
6
   4.7%
3
   3.4%
9
   4.1%
Mixed epithelial tumour
4
   3.1%
1
   1.1%
5
   2.3%
Mucinous
2
   1.6%
1
   1.1%
3
   1.4%
Undifferentiated carcinoma
2
   1.6%
1
   1.1%
3
   1.4%
Fallopian tube carcinoma
0
   0.0%
2
   2.2%
2
   0.9%
Transitional carcinoma (brenner)
0
   0.0%
1
   1.1%
1
   0.5%
Transitional carcinoma (no brenner)
0
   0.0%
1
   1.1%
1
   0.5%
Unknown
6
   4.7%
7
   7.9%
13
   6.0%
Platinum sensitivity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
Partially Platinum Sensitive
80
  62.0%
47
  52.8%
127
  58.3%
Fully Platinum Sensitive
48
  37.2%
41
  46.1%
89
  40.8%
Missing
1
   0.8%
1
   1.1%
2
   0.9%
BRCA 1/2 status tested  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
Positive
15
  11.6%
19
  21.3%
34
  15.6%
Negative
68
  52.7%
32
  36.0%
100
  45.9%
Unknown
1
   0.8%
0
   0.0%
1
   0.5%
Not tested
45
  34.9%
38
  42.7%
83
  38.1%
ECOG performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
PS 0
63
  48.8%
45
  50.6%
108
  49.5%
PS 1
41
  31.8%
15
  16.9%
56
  25.7%
PS 2
3
   2.3%
3
   3.4%
6
   2.8%
Missing
22
  17.1%
26
  29.2%
48
  22.0%
[1]
Measure Description:

Eastern Cooperative Oncology Group performance status:

0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Prior surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
118
  91.5%
81
  91.0%
199
  91.3%
Surgery residual disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
58
  45.0%
26
  29.2%
84
  38.5%
Prior radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
4
   3.1%
3
   3.4%
7
   3.2%
Prior chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
129
 100.0%
88
  98.9%
217
  99.5%
Number of prior chemotherapy lines  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
None
0
   0.0%
1
   1.1%
1
   0.5%
1 prior line
22
  17.1%
37
  41.6%
59
  27.1%
2 prior lines
48
  37.2%
23
  25.8%
71
  32.6%
3 prior lines
32
  24.8%
11
  12.4%
43
  19.7%
4-8 prior lines
27
  20.9%
17
  19.1%
44
  20.2%
Best response to prior therapy regimen   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 89 participants 218 participants
Complete Response
24
  18.6%
31
  34.8%
55
  25.2%
Partial Response
31
  24.0%
23
  25.8%
54
  24.8%
Stable Disease
36
  27.9%
12
  13.5%
48
  22.0%
Disease recurrence/Progression disease
26
  20.2%
6
   6.7%
32
  14.7%
Not Evaluable/Not done/Unknown
12
   9.3%
17
  19.1%
29
  13.3%
[1]
Measure Description: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
1.Primary Outcome
Title Progression-Free Survival
Hide Description PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
Overall Number of Participants Analyzed 218
Median (95% Confidence Interval)
Unit of Measure: months
9.46
(7.9 to 10.9)
2.Primary Outcome
Title Progression Free Survival by Prior Antiangiogenic Treatment
Hide Description PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Hide Arm/Group Description:
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Overall Number of Participants Analyzed 129 89
Median (95% Confidence Interval)
Unit of Measure: months
7.59
(6.4 to 10.0)
12.45
(9.4 to 14.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prior Use of Antiangiogenics, No Prior Use of Antiangiogenics
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Primary Outcome
Title Progression Free Survival by BRCA1/2 Status
Hide Description PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Positive BRCA Negative
Hide Arm/Group Description:
Patients with Positive BRCA
Patients with Negative BRCA
Overall Number of Participants Analyzed 34 100
Median (95% Confidence Interval)
Unit of Measure: months
9.23
(6.0 to 17.1)
8.97
(7.1 to 10.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positive BRCA, Negative
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Primary Outcome
Title Progression Free Survival by Platinum Sensitivity
Hide Description PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fully Platinum Sensitivity Partially Platinum Sensitivity
Hide Arm/Group Description:
Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
Overall Number of Participants Analyzed 89 127
Median (95% Confidence Interval)
Unit of Measure: months
9.26
(7.1 to 12.5)
9.46
(7.4 to 11.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fully Platinum Sensitivity, Partially Platinum Sensitivity
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Best Tumor Response
Hide Description Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
Overall Number of Participants Analyzed 218
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
24
  11.0%
Partial response
57
  26.1%
Stable disease
59
  27.1%
Progressive disease
62
  28.4%
Not evaluable/Not done
16
   7.3%
6.Secondary Outcome
Title Best Response by Prior Antiangiogenic Treatment
Hide Description Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Hide Arm/Group Description:
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Overall Number of Participants Analyzed 129 89
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive disease
46
  35.7%
16
  18.0%
Stable disease
32
  24.8%
27
  30.3%
Partial response
27
  20.9%
30
  33.7%
Complete response
11
   8.5%
13
  14.6%
Not evaluable/Not done
13
  10.1%
3
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prior Use of Antiangiogenics, No Prior Use of Antiangiogenics
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time Frame From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
Overall Number of Participants Analyzed 218
Median (95% Confidence Interval)
Unit of Measure: months
23.56
(18.1 to 34.1)
8.Secondary Outcome
Title Overall Survival by Prior Antiangiogenic Treatment
Hide Description Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time Frame From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Hide Arm/Group Description:
Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Overall Number of Participants Analyzed 129 89
Median (95% Confidence Interval)
Unit of Measure: months
21.85
(16.7 to 39.6)
26.28
(18.1 to 40.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prior Use of Antiangiogenics, No Prior Use of Antiangiogenics
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Overall Survival by BRCA1/2 Status
Hide Description Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time Frame From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Positive BRCA Negative
Hide Arm/Group Description:
Patients with Positive BRCA
Patients with Negative BRCA
Overall Number of Participants Analyzed 34 100
Median (95% Confidence Interval)
Unit of Measure: months
23.56
(16.1 to 40.1)
21.85 [1] 
(16.7 to NA)
[1]
Not reached: the last observation is censored
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positive BRCA, Negative
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
10.Secondary Outcome
Title Overall Survival by Platinum Sensitivity
Hide Description Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time Frame From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
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[Not Specified]
Arm/Group Title Fully Platinum Sensitivity Partially Platinum Sensitivity
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Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin.
Overall Number of Participants Analyzed 89 127
Median (95% Confidence Interval)
Unit of Measure: months
23.56
(16.7 to 34.1)
26.05
(17.7 to 39.6)
11.Secondary Outcome
Title Change From Baseline to Best Post-baseline ECOG Performance Status Score
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Eastern Cooperative Oncology Group performance status (ECOG):

0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Time Frame Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
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[Not Specified]
Arm/Group Title Full Analysis Set
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The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD.
Overall Number of Participants Analyzed 218
Measure Type: Count of Participants
Unit of Measure: Participants
Less than 0 (improvement)
24
  11.0%
0 (no change)
125
  57.3%
More than 0 to 2 (deterioration)
14
   6.4%
Missing
55
  25.2%
12.Secondary Outcome
Title Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
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Eastern Cooperative Oncology Group performance status (ECOG):

0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Time Frame Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
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[Not Specified]
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
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Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
Overall Number of Participants Analyzed 129 89
Measure Type: Count of Participants
Unit of Measure: Participants
Less than 0 (improvement)
14
  10.9%
10
  11.2%
0 (no change)
83
  64.3%
42
  47.2%
More than 0 to 2 (deterioration)
5
   3.9%
9
  10.1%
Missing
27
  20.9%
28
  31.5%
Time Frame From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Adverse Event Reporting Description Two patients were excluded from the safety set because of missing PLD treatment data
 
Arm/Group Title Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Hide Arm/Group Description Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib
All-Cause Mortality
Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Affected / at Risk (%) Affected / at Risk (%)
Total   30/129 (23.26%)      12/89 (13.48%)    
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Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/129 (17.83%)      14/89 (15.73%)    
Blood and lymphatic system disorders     
Anaemia * 1  3/129 (2.33%)  3 1/89 (1.12%)  1
Febrile neutropenia * 1  4/129 (3.10%)  4 4/89 (4.49%)  4
Neutropenia * 1  5/129 (3.88%)  7 4/89 (4.49%)  4
Pancytopenia * 1  2/129 (1.55%)  2 1/89 (1.12%)  1
Thrombocytopenia * 1  4/129 (3.10%)  5 1/89 (1.12%)  1
Leukopenia * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Gastrointestinal disorders     
Diarrhoea * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Dysphagia * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Gastrointestinal obstruction * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Gastrooesophageal reflux disease * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Nausea * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Oesophagitis * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Retching * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Vomiting * 1  4/129 (3.10%)  6 1/89 (1.12%)  1
Abdominal pain * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Enteritis * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Intestinal obstruction * 1  0/129 (0.00%)  0 1/89 (1.12%)  3
General disorders     
Asthenia * 1  1/129 (0.78%)  1 1/89 (1.12%)  1
Disease progression * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Fatigue * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Oedema * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Pyrexia * 1  2/129 (1.55%)  2 0/89 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Infections and infestations     
Device related infection * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Escherichia infection * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Infusion site infection * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Pneumocystis jirovecii pneumonia * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Pneumonia * 1  2/129 (1.55%)  2 0/89 (0.00%)  0
Respiratory tract infection * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Sepsis * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Upper respiratory tract infection * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Urosepsis * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Bacteraemia * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Clostridium difficile infection * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Investigations     
Blood alkaline phosphatase increased * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Blood electrolytes decreased * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Platelet count decreased * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Transaminases increased * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/129 (0.78%)  2 0/89 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic cancer metastatic * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Nervous system disorders     
Cerebral haemorrhage * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Convulsion * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Psychiatric disorders     
Mood altered * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Renal and urinary disorders     
Azotaemia * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Renal failure * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Renal failure acute * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Respiratory, thoracic and mediastinal disorders     
Dysphonia * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Dyspnoea * 1  4/129 (3.10%)  4 0/89 (0.00%)  0
Pleural effusion * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Pulmonary embolism * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pyoderma gangrenosum * 1  1/129 (0.78%)  1 0/89 (0.00%)  0
Surgical and medical procedures     
Off label use * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
Vascular disorders     
Embolism * 1  0/129 (0.00%)  0 1/89 (1.12%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prior Use of Antiangiogenics No Prior Use of Antiangiogenics
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   106/129 (82.17%)      78/89 (87.64%)    
Blood and lymphatic system disorders     
Anaemia * 1  45/129 (34.88%)  99 25/89 (28.09%)  48
Leukopenia * 1  18/129 (13.95%)  36 7/89 (7.87%)  22
Neutropenia * 1  57/129 (44.19%)  162 46/89 (51.69%)  152
Thrombocytopenia * 1  22/129 (17.05%)  34 6/89 (6.74%)  14
Gastrointestinal disorders     
Constipation * 1  15/129 (11.63%)  22 12/89 (13.48%)  15
Diarrhoea * 1  10/129 (7.75%)  12 8/89 (8.99%)  10
Nausea * 1  39/129 (30.23%)  63 26/89 (29.21%)  36
Stomatitis * 1  5/129 (3.88%)  5 5/89 (5.62%)  6
Vomiting * 1  30/129 (23.26%)  42 15/89 (16.85%)  19
General disorders     
Asthenia * 1  35/129 (27.13%)  64 37/89 (41.57%)  61
Fatigue * 1  11/129 (8.53%)  11 5/89 (5.62%)  6
Mucosal inflammation * 1  10/129 (7.75%)  16 15/89 (16.85%)  22
Investigations     
Neutrophil count decreased * 1  9/129 (6.98%)  30 7/89 (7.87%)  13
Metabolism and nutrition disorders     
Decreased appetite * 1  13/129 (10.08%)  21 8/89 (8.99%)  8
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  4/129 (3.10%)  6 12/89 (13.48%)  17
Skin hyperpigmentation * 1  1/129 (0.78%)  1 5/89 (5.62%)  5
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
Results Point of Contact
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Name/Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Organization: Pharma Mar S.A.
Phone: 0034 91846 60 00
EMail: clinicaltrials@pharmamar.com
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Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02825420    
Other Study ID Numbers: ET-D-031-14
First Submitted: June 27, 2016
First Posted: July 7, 2016
Results First Submitted: July 28, 2021
Results First Posted: October 29, 2021
Last Update Posted: October 29, 2021