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Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients (CORAIL)

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ClinicalTrials.gov Identifier: NCT02421588
Recruitment Status : Completed
First Posted : April 20, 2015
Results First Posted : March 5, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Lurbinectedin (PM01183)
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: Topotecan
Enrollment 442
Recruitment Details First randomization/first study treatment administration took place on 26JUN2015. The cutoff date for results was 12OCT2018. 534 patients were screened; 442 were randomized at 83 sites/12 countries. 10 patients did not receive the study treatment.
Pre-assignment Details IC;Age≥18 years;confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer;Platinum-resistant disease;ECOG PS≤2;Adequate hematological, renal, metabolic, and hepatic function
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Period Title: Overall Study
Started 221 221
Completed 0 0
Not Completed 221 221
Reason Not Completed
Non-treatment-related AE             8             8
Progressive disease             152             135
Death             11             3
Physician Decision             8             17
Other reason not specified             3             1
Symptomatic deterioration             13             19
Treatment-related AE             10             14
Withdrawal by Subject             14             16
Not treated             2             8
Arm/Group Title Lurbinectedin Control (PLD or Topotecan) Total
Hide Arm/Group Description 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual Total of all reporting groups
Overall Number of Baseline Participants 221 221 442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
126
  57.0%
141
  63.8%
267
  60.4%
>=65 years
95
  43.0%
80
  36.2%
175
  39.6%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 221 participants 221 participants 442 participants
63.0
(25 to 85)
59.0
(28 to 87)
61.0
(25 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Female
221
 100.0%
221
 100.0%
442
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
1
   0.2%
Asian
2
   0.9%
3
   1.4%
5
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   2.7%
2
   0.9%
8
   1.8%
White
192
  86.9%
201
  91.0%
393
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
21
   9.5%
14
   6.3%
35
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
United States 39 40 79
Romania 11 11 22
Spain 40 46 86
United Kingdom 17 14 31
Austria 3 4 7
Belgium 21 19 40
Bulgaria 5 5 10
Czechia 5 5 10
France 19 12 31
Hungary 9 14 23
Italy 47 47 94
Serbia 5 4 9
Body mass index  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
≤20 kg/m^2
26
  11.8%
37
  16.7%
63
  14.3%
20-25 kg/m^2
82
  37.1%
84
  38.0%
166
  37.6%
25-30 kg/m^2
62
  28.1%
51
  23.1%
113
  25.6%
>30 kg/m^2
50
  22.6%
49
  22.2%
99
  22.4%
Unknown
1
   0.5%
0
   0.0%
1
   0.2%
ECOG PS   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
PS 0
126
  57.0%
123
  55.7%
249
  56.3%
PS 1
87
  39.4%
94
  42.5%
181
  41.0%
PS 2
8
   3.6%
4
   1.8%
12
   2.7%
[1]
Measure Description: ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
Primary site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Ovarian
196
  88.7%
195
  88.2%
391
  88.5%
Fallopian
11
   5.0%
13
   5.9%
24
   5.4%
Peritoneal
14
   6.3%
13
   5.9%
27
   6.1%
Histology type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Serous/Papillary
181
  81.9%
199
  90.0%
380
  86.0%
Endometrioid
14
   6.3%
6
   2.7%
20
   4.5%
Clear cell
10
   4.5%
12
   5.4%
22
   5.0%
Mucinous
3
   1.4%
1
   0.5%
4
   0.9%
Other
13
   5.9%
3
   1.4%
16
   3.6%
Histologic grade  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Well differentiated
16
   7.2%
15
   6.8%
31
   7.0%
Moderately differentiated
21
   9.5%
24
  10.9%
45
  10.2%
Poorly differentiated/Undifferentiated
154
  69.7%
143
  64.7%
297
  67.2%
Unknown
30
  13.6%
39
  17.6%
69
  15.6%
BRCA status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
BRCA1
10
   4.5%
8
   3.6%
18
   4.1%
BRCA2
4
   1.8%
3
   1.4%
7
   1.6%
Not mutated
64
  29.0%
61
  27.6%
125
  28.3%
Unknown
143
  64.7%
149
  67.4%
292
  66.1%
Intestinal sub-occlusion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
9
   4.1%
10
   4.5%
19
   4.3%
No
212
  95.9%
211
  95.5%
423
  95.7%
Clinically evident ascites  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
35
  15.8%
39
  17.6%
74
  16.7%
No
186
  84.2%
182
  82.4%
368
  83.3%
Radiological presence of ascites  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
59
  26.7%
71
  32.1%
130
  29.4%
No
162
  73.3%
150
  67.9%
312
  70.6%
Prior radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
6
   2.7%
5
   2.3%
11
   2.5%
No
215
  97.3%
216
  97.7%
431
  97.5%
Prior Cytoreductive surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
198
  89.6%
204
  92.3%
402
  91.0%
No
23
  10.4%
17
   7.7%
40
   9.0%
Other prior surgical procedures  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Yes
86
  38.9%
81
  36.7%
167
  37.8%
No
135
  61.1%
140
  63.3%
275
  62.2%
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 221 participants 221 participants 442 participants
65.8
(37.0 to 125.0)
63.0
(39.0 to 142.8)
64.4
(37.0 to 142.8)
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 221 participants 221 participants 442 participants
161.0
(147 to 177)
161.0
(144 to 183)
161.0
(144 to 183)
Body Surface Area  
Median (Full Range)
Unit of measure:  M^2
Number Analyzed 221 participants 221 participants 442 participants
1.7
(1.3 to 2.4)
1.7
(1.3 to 2.4)
1.7
(1.3 to 2.4)
Body mass index  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 221 participants 221 participants 442 participants
25.1
(15.0 to 47.9)
24.7
(14.5 to 56.5)
24.9
(14.5 to 56.5)
First diagnosis to randomization  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 221 participants 221 participants 442 participants
23.4
(7 to 294)
20.7
(4 to 184)
22.05
(4 to 294)
Sites involved  
Median (Full Range)
Unit of measure:  Number of sites
Number Analyzed 221 participants 221 participants 442 participants
2.0
(1 to 5)
2.0
(1 to 7)
2.0
(1 to 7)
1.Primary Outcome
Title Progression-free Survival by Independent Review Committee
Hide Description The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Time Frame Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 221 221
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.1 to 3.7)
3.6
(2.7 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6294
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.057
Confidence Interval (2-Sided) 95%
0.854 to 1.309
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments PFS (%) at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 6 months
Estimated Value 24.3
Confidence Interval (2-Sided) 95%
18.4 to 30.7
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments PFS (%) at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 6 months
Estimated Value 27.5
Confidence Interval (2-Sided) 95%
20.9 to 34.4
Estimation Comments Percent of Participants
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS (%) at 6 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5032
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments PFS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 12 months
Estimated Value 8.3
Confidence Interval (2-Sided) 95%
4.7 to 13.3
Estimation Comments Percent of Participants
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments PFS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 12 months
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
3.3 to 12.5
Estimation Comments Percent of Participants
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS (%) at 12 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6742
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival by Investigator's Assessment
Hide Description The primary endpoint was PFS by Investigator's Assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Time Frame Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 221 221
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(3.6 to 3.9)
3.7
(3.5 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7673
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.987
Confidence Interval (2-Sided) 95%
0.805 to 1.209
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments PFS (%) at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 6 months
Estimated Value 29.0
Confidence Interval (2-Sided) 95%
22.8 to 35.4
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments PFS (%) at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS at 6 months
Estimated Value 27.4
Confidence Interval (2-Sided) 95%
21.3 to 33.9
Estimation Comments Percent of Participants
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS (%) at 6 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7385
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments PFS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS (%) at 12 months
Estimated Value 8.2
Confidence Interval (2-Sided) 95%
4.8 to 12.7
Estimation Comments Percent of Participants
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments PFS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter PFS (%) at 12 months
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
4.2 to 12.2
Estimation Comments Percent of Participants
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments PFS (%) at 12 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8245
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Calculated from the date of randomization to the date of death (death event) or last contact (in this case, survival was censored on that date).
Time Frame From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 221 221
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(9.0 to 14.2)
10.9
(9.3 to 12.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments OS between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8021
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.956
Confidence Interval (2-Sided) 95%
0.772 to 1.183
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments OS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter OS at 12 months
Estimated Value 48.2
Confidence Interval (2-Sided) 95%
41.3 to 54.8
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments OS (%) at 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter OS (%) at 12 months
Estimated Value 45.3
Confidence Interval (2-Sided) 95%
38.4 to 52.0
Estimation Comments Percent of Participants
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments OS (%) at 12 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5515
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments OS (%) at 24 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter OS (%) at 24 months
Estimated Value 22.3
Confidence Interval (2-Sided) 95%
16.8 to 28.2
Estimation Comments Percent of Participants
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments OS (%) at 24 months
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter OS (%) at 24 months
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
17.1 to 28.7
Estimation Comments Percent of Participants
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments OS (%) at 24 months between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9253
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
4.Secondary Outcome
Title Overall Response Rate (ORR) by Independent Review Committee
Hide Description

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR.

Time Frame At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 221 221
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
3
   1.4%
3
   1.4%
Partial response
29
  13.1%
25
  11.3%
Stable disease
90
  40.7%
97
  43.9%
Progressive disease
83
  37.6%
72
  32.6%
Unknown
16
   7.2%
24
  10.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments Overall response rate
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR
Estimated Value 14.5
Confidence Interval (2-Sided) 95%
10.1 to 19.8
Estimation Comments Percent of Participants
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments Overall response rate
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
8.6 to 17.8
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments Overall response rate between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6772
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Overall Response Rate by Investigator's Assessment
Hide Description

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR.

Time Frame At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 221 221
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
3
   1.4%
2
   0.9%
Partial response
32
  14.5%
35
  15.8%
Stable disease
107
  48.4%
94
  42.5%
Progressive disease
63
  28.5%
68
  30.8%
Unknown
16
   7.2%
22
  10.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments Overall response rate (ORR)
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR
Estimated Value 15.8
Confidence Interval (2-Sided) 95%
11.3 to 21.3
Estimation Comments Percent of Participants
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments Overall response rate (ORR)
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall response rate (ORR)
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
12.1 to 22.3
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments Overall response rate (ORR) between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8976
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Duration of Response by Independent Review Committee
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Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.

Time Frame The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have CR or PR
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 32 28
Median (95% Confidence Interval)
Unit of Measure: months
4.0
(1.9 to 5.7)
3.7
(3.6 to 7.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments Duration of response between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2631
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.406
Confidence Interval (2-Sided) 95%
0.769 to 2.569
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Duration of Response by Investigator's Assessment
Hide Description

Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.

Time Frame The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have CR or PR
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 35 37
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(3.6 to 5.8)
3.7
(3.2 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Duration of response between treatments
Statistical Test of Hypothesis P-Value 0.8276
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.056
Confidence Interval (2-Sided) 95%
0.64 to 1.743
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Best Response According to Tumor Marker Evaluation (CA-125)
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Best response according to tumor marker evaluation (CA-125): defined as the best response obtained according to GCIG criteria. Tumor marker assessments were performed at baseline and every eight weeks from randomization until evidence of PD. Progression based on serum CA-125 levels was defined on the basis of a progressive serial elevation of serum CA-125 according to:

A. Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or B. Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or C. Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart.

Time Frame At baseline and every eight weeks from randomization until evidence of PD, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description:
3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL
Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
Overall Number of Participants Analyzed 173 165
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
13
   7.5%
3
   1.8%
Partial response
33
  19.1%
29
  17.6%
Stable disease
95
  54.9%
94
  57.0%
Progressive disease
17
   9.8%
16
   9.7%
Unknown
15
   8.7%
23
  13.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lurbinectedin
Comments ORR (%) by CA-125
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR (%)
Estimated Value 26.6
Confidence Interval (2-Sided) 95%
20.2 to 33.8
Estimation Comments Percent of Participants
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control (PLD or Topotecan)
Comments ORR (%) by CA-125
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR (%)
Estimated Value 19.4
Confidence Interval (2-Sided) 95%
13.7 to 26.3
Estimation Comments Percent of Participants
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lurbinectedin, Control (PLD or Topotecan)
Comments ORR (%) by CA-125 between treatments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1231
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Participants were assessed through study completion, approximately 3 years
Adverse Event Reporting Description A total of 432 of 442 patients randomized in this study were treated (n=219 in the Lurbinectedin arm; n=213 in the Control arm [PLD or topotecan]) and therefore were evaluable for safety. Ten patients were not treated after randomization: two in the Lurbinectedin arm and eight in the Control arm (PLD or topotecan).
 
Arm/Group Title Lurbinectedin Control (PLD or Topotecan)
Hide Arm/Group Description 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual
All-Cause Mortality
Lurbinectedin Control (PLD or Topotecan)
Affected / at Risk (%) Affected / at Risk (%)
Total   170/219 (77.63%)      171/213 (80.28%)    
Hide Serious Adverse Events
Lurbinectedin Control (PLD or Topotecan)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/219 (42.01%)      85/213 (39.91%)    
Blood and lymphatic system disorders     
Anaemia  1  8/219 (3.65%)  14 12/213 (5.63%)  19
Febrile neutropenia  1  14/219 (6.39%)  14 12/213 (5.63%)  13
Leucopenia  1  3/219 (1.37%)  3 3/213 (1.41%)  4
Neutropenia  1  11/219 (5.02%)  14 13/213 (6.10%)  14
Thrombocytopenia  1  9/219 (4.11%)  9 11/213 (5.16%)  20
Leukocytosis  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Cardiac disorders     
Cardiac failure  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Cardiorespiratory arrest  1  3/219 (1.37%)  3 0/213 (0.00%)  0
Coronary artery disease  1  1/219 (0.46%)  3 0/213 (0.00%)  0
Myocardial infarction  1  1/219 (0.46%)  1 1/213 (0.47%)  1
Atrial fibrillation  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Cardiac tamponade  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Gastrointestinal disorders     
Abdominal distension  1  2/219 (0.91%)  2 0/213 (0.00%)  0
Abdominal pain  1  6/219 (2.74%)  8 6/213 (2.82%)  6
Ascites  1  4/219 (1.83%)  6 7/213 (3.29%)  11
Constipation  1  2/219 (0.91%)  2 0/213 (0.00%)  0
Diarrhoea  1  2/219 (0.91%)  2 2/213 (0.94%)  2
Intestinal obstruction  1  24/219 (10.96%)  32 21/213 (9.86%)  28
Intestinal perforation  1  1/219 (0.46%)  1 1/213 (0.47%)  1
Nausea  1  7/219 (3.20%)  8 4/213 (1.88%)  5
Oesophageal stenosis  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Proctalgia  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Vomiting  1  10/219 (4.57%)  10 4/213 (1.88%)  5
Gastrooesophageal reflux disease  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Neutropenic colitis  1  0/219 (0.00%)  0 3/213 (1.41%)  3
Oesophageal ulcer  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Oesophagitis  1  0/219 (0.00%)  0 1/213 (0.47%)  1
General disorders     
Fatigue  1  2/219 (0.91%)  3 2/213 (0.94%)  2
General physical health deterioration  1  1/219 (0.46%)  1 4/213 (1.88%)  5
Influenza like illness  1  1/219 (0.46%)  1 1/213 (0.47%)  1
Pyrexia  1  3/219 (1.37%)  3 1/213 (0.47%)  1
Vessel puncture site haematoma  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Chest pain  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Malaise  1  0/219 (0.00%)  0 1/213 (0.47%)  2
Mucosal inflammation  1  0/219 (0.00%)  0 3/213 (1.41%)  4
Pain  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Hepatobiliary disorders     
Bile duct obstruction  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Cholangitis  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Cholecystitis  1  2/219 (0.91%)  2 0/213 (0.00%)  0
Portal vein thrombosis  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Infections and infestations     
Abdominal wall abscess  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Atypical pneumonia  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Bacteraemia  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Gastroenteritis  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Herpes virus infection  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Neutropenic sepsis  1  2/219 (0.91%)  2 0/213 (0.00%)  0
Pneumonia  1  2/219 (0.91%)  2 0/213 (0.00%)  0
Sepsis  1  5/219 (2.28%)  5 1/213 (0.47%)  1
Septic shock  1  1/219 (0.46%)  1 2/213 (0.94%)  2
Skin infection  1  1/219 (0.46%)  3 0/213 (0.00%)  0
Urinary tract infection  1  4/219 (1.83%)  4 3/213 (1.41%)  3
Infection  1  0/219 (0.00%)  0 2/213 (0.94%)  2
Influenza  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Peritonitis  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Injury, poisoning and procedural complications     
Subdural haematoma  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Toxicity to various agents  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Femur fracture  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Gastrointestinal stoma complication  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Transfusion reaction  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Investigations     
Alanine aminotransferase increased  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Blood creatinine increased  1  3/219 (1.37%)  3 0/213 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Transaminases increased  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  4/219 (1.83%)  4 2/213 (0.94%)  2
Hyperclycemia  1  1/219 (0.46%)  2 0/213 (0.00%)  0
Hypoalbuminemia  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Hypokalaemia  1  1/219 (0.46%)  1 2/213 (0.94%)  2
Hyponatraemia  1  2/219 (0.91%)  3 1/213 (0.47%)  1
Malnutrition  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  2/219 (0.91%)  2 1/213 (0.47%)  1
Hypoglycaemic coma  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Paresis  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Toxic encephalopathy  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Neuropathy peripheral  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Renal and urinary disorders     
Haematuria  1  1/219 (0.46%)  1 1/213 (0.47%)  2
Acute kidney injury  1  0/219 (0.00%)  0 1/213 (0.47%)  2
Hydronephrosis  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/219 (0.91%)  2 4/213 (1.88%)  5
Lung disorder  1  1/219 (0.46%)  1 0/213 (0.00%)  0
Pleural effusion  1  3/219 (1.37%)  3 3/213 (1.41%)  5
Pulmonary embolism  1  3/219 (1.37%)  3 3/213 (1.41%)  3
Pulmonary oedema  1  1/219 (0.46%)  2 0/213 (0.00%)  0
Pneumonitis  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Pneumothorax  1  0/219 (0.00%)  0 1/213 (0.47%)  1
Vascular disorders     
Embolism  1  2/219 (0.91%)  2 1/213 (0.47%)  1
Phlebitis  1  1/219 (0.46%)  1 1/213 (0.47%)  1
Venous thrombosis  1  2/219 (0.91%)  2 1/213 (0.47%)  1
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lurbinectedin Control (PLD or Topotecan)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   212/219 (96.80%)      211/213 (99.06%)    
Blood and lymphatic system disorders     
Anaemia  1  57/219 (26.03%)  155 77/213 (36.15%)  201
Leucopenia  1  23/219 (10.50%)  39 21/213 (9.86%)  38
Neutropenia  1  73/219 (33.33%)  167 89/213 (41.78%)  211
Thrombocytopenia  1  20/219 (9.13%)  46 39/213 (18.31%)  77
Gastrointestinal disorders     
Abdominal distension  1  12/219 (5.48%)  16 10/213 (4.69%)  12
Abdominal pain  1  74/219 (33.79%)  145 52/213 (24.41%)  73
Ascites  1  14/219 (6.39%)  15 21/213 (9.86%)  43
Constipation  1  72/219 (32.88%)  118 61/213 (28.64%)  84
Diarrhoea  1  45/219 (20.55%)  71 35/213 (16.43%)  58
Nausea  1  156/219 (71.23%)  390 92/213 (43.19%)  169
Dyspepsia  1  14/219 (6.39%)  16 15/213 (7.04%)  16
Vomiting  1  87/219 (39.73%)  196 58/213 (27.23%)  88
General disorders     
Fatigue  1  133/219 (60.73%)  328 113/213 (53.05%)  206
Mucosal inflammation  1  22/219 (10.05%)  26 68/213 (31.92%)  145
Oedema  1  25/219 (11.42%)  32 13/213 (6.10%)  15
Pyrexia  1  25/219 (11.42%)  29 33/213 (15.49%)  40
Infections and infestations     
Upper respiratory tract infection  1  11/219 (5.02%)  14 20/213 (9.39%)  21
Urinary tract infection  1  21/219 (9.59%)  25 15/213 (7.04%)  18
Investigations     
Weight decreased  1  10/219 (4.57%)  14 14/213 (6.57%)  16
Metabolism and nutrition disorders     
Decreased appetite  1  51/219 (23.29%)  81 47/213 (22.07%)  69
Hypokalaemia  1  15/219 (6.85%)  26 15/213 (7.04%)  28
Musculoskeletal and connective tissue disorders     
Arthralgia  1  15/219 (6.85%)  20 5/213 (2.35%)  7
Back pain  1  13/219 (5.94%)  17 19/213 (8.92%)  22
Nervous system disorders     
Headache  1  26/219 (11.87%)  36 9/213 (4.23%)  10
Neuropathy peripheral  1  19/219 (8.68%)  32 15/213 (7.04%)  20
Psychiatric disorders     
Sleep disorder  1  22/219 (10.05%)  23 10/213 (4.69%)  10
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/219 (7.76%)  19 26/213 (12.21%)  33
Dyspnoea  1  29/219 (13.24%)  37 23/213 (10.80%)  34
Skin and subcutaneous tissue disorders     
Alopecia  1  5/219 (2.28%)  5 30/213 (14.08%)  33
Palmar-plantar erythrodysaesthesia syndrome  1  3/219 (1.37%)  3 51/213 (23.94%)  98
Rash  1  8/219 (3.65%)  9 14/213 (6.57%)  25
Vascular disorders     
Hypertension  1  12/219 (5.48%)  22 4/213 (1.88%)  9
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pharma Mar S.A.
Organization: Pharma Mar S.A.
Phone: 0034918466000
EMail: clinicaltrials@pharmamar.com
Layout table for additonal information
Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02421588    
Other Study ID Numbers: PM1183-C-004-14
First Submitted: April 10, 2015
First Posted: April 20, 2015
Results First Submitted: February 19, 2020
Results First Posted: March 5, 2020
Last Update Posted: April 3, 2020