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A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01525589
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: PM01183
Enrollment 111
Recruitment Details

The first patient was included on 27JUN12 and the first study treatment administration was on 28JUN12.

The cutoff date for the results was 24OCT18. A total of 111 patients were included in the 3 cohorts of the study: 56 in Cohort A (BRCA+), 20 in Cohort A1 (BRCA+/PARPi), 35 in Cohort B (Unselected).

Pre-assignment Details  
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description Patients with known deleterious BRCA1/2 mutation status at study entry Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Period Title: Overall Study
Started 56 20 35
Completed 0 0 0
Not Completed 56 20 35
Reason Not Completed
Non-treatment-related AE             1             0             0
Progressive disease             48             15             29
Never treated             2             0             0
Physician Decision             4             2             2
Death             0             0             2
Treatment-related AE             1             1             2
Other reasons             0             1             0
Withdrawal by Subject             0             1             0
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected) Total
Hide Arm/Group Description Patients with known deleterious BRCA1/2 mutation status at study entry Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Total of all reporting groups
Overall Number of Baseline Participants 56 20 35 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  91.1%
19
  95.0%
30
  85.7%
100
  90.1%
>=65 years
5
   8.9%
1
   5.0%
5
  14.3%
11
   9.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants 20 participants 35 participants 111 participants
42.5
(30 to 73)
45.0
(31 to 66)
52.0
(32 to 70)
45.0
(30 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Female
56
 100.0%
20
 100.0%
35
 100.0%
111
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 56 participants 20 participants 35 participants 111 participants
Caucasian
50
  89.3%
16
  80.0%
32
  91.4%
98
  88.3%
Black
2
   3.6%
0
   0.0%
1
   2.9%
3
   2.7%
Asian
1
   1.8%
1
   5.0%
0
   0.0%
2
   1.8%
Hispanic
2
   3.6%
1
   5.0%
2
   5.7%
5
   4.5%
Unknown
1
   1.8%
2
  10.0%
0
   0.0%
3
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
United States 35 16 9 60
Spain 21 4 26 51
ECOG PS   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
PS 0
32
  57.1%
10
  50.0%
22
  62.9%
64
  57.7%
PS 1
24
  42.9%
10
  50.0%
13
  37.1%
47
  42.3%
[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
Sites of disease at diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Left breast
26
  46.4%
11
  55.0%
18
  51.4%
55
  49.5%
Right breast
28
  50.0%
9
  45.0%
15
  42.9%
52
  46.8%
Bilateral
2
   3.6%
0
   0.0%
2
   5.7%
4
   3.6%
Histology type at diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Ductal carcinoma
54
  96.4%
20
 100.0%
34
  97.1%
108
  97.3%
Lobular carcinoma
2
   3.6%
0
   0.0%
0
   0.0%
2
   1.8%
Lobular and ductal carcinoma
0
   0.0%
0
   0.0%
1
   2.9%
1
   0.9%
Histology grade at diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Well differentiated
3
   5.4%
0
   0.0%
1
   2.9%
4
   3.6%
Moderately differentiated
10
  17.9%
8
  40.0%
13
  37.1%
31
  27.9%
Poorly differentiated
31
  55.4%
11
  55.0%
17
  48.6%
59
  53.2%
Unknown
12
  21.4%
1
   5.0%
4
  11.4%
17
  15.3%
[1]
Measure Description:

Well differentiated: The cells are slower-growing, and look more like normal breast tissue.

Moderately differentiated: The cells are growing at a speed of and look like cells somewhere between grades 1 and 3.

Poorly differentiated: The cancer cells look very different from normal cells and will probably grow and spread faster.

Stage at diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Stage I
9
  16.1%
3
  15.0%
0
   0.0%
12
  10.8%
Stage II
26
  46.4%
9
  45.0%
13
  37.1%
48
  43.2%
Stage III
16
  28.6%
6
  30.0%
19
  54.3%
41
  36.9%
Stage IV
5
   8.9%
2
  10.0%
3
   8.6%
10
   9.0%
[1]
Measure Description:

Stage I describes invasive breast cancer (cancer cells are breaking through to or invading normal surrounding breast tissue) Stage II. The cancer has grown, spread, or both. Stage III. The cancer has not spread to bones or organs, but it's considered advanced, and it's harder to fight.

Stage IV describes invasive breast cancer that has spread beyond the breast and nearby lymph nodes to other organs of the body, such as the lungs, distant lymph nodes, skin, bones, liver, or brain.

BRCA deleterious mutation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
BRCA1
33
  58.9%
10
  50.0%
0
   0.0%
43
  38.7%
BRCA2
23
  41.1%
9
  45.0%
0
   0.0%
32
  28.8%
Both
0
   0.0%
1
   5.0%
0
   0.0%
1
   0.9%
Not applicable
0
   0.0%
0
   0.0%
35
 100.0%
35
  31.5%
Hormonal status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
Triple negative
33
  58.9%
7
  35.0%
17
  48.6%
57
  51.4%
ER and/or PR positive and HER2 negative
21
  37.5%
12
  60.0%
14
  40.0%
47
  42.3%
ER and/or PR positive and HER2 positive
2
   3.6%
1
   5.0%
3
   8.6%
6
   5.4%
ER and PR negative and HER2 positive
0
   0.0%
0
   0.0%
1
   2.9%
1
   0.9%
Sites at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
<3 sites
23
  41.1%
7
  35.0%
21
  60.0%
51
  45.9%
≥3 sites
33
  58.9%
13
  65.0%
14
  40.0%
60
  54.1%
Prior surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
53
  94.6%
19
  95.0%
34
  97.1%
106
  95.5%
Prior radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 20 participants 35 participants 111 participants
44
  78.6%
18
  90.0%
32
  91.4%
94
  84.7%
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 56 participants 20 participants 35 participants 111 participants
69.2
(48.4 to 107.3)
59.8
(48.5 to 98.8)
71.7
(43.0 to 153.6)
68.1
(43.0 to 153.6)
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 56 participants 20 participants 35 participants 111 participants
162.5
(150.0 to 178.0)
161.0
(148.0 to 173.0)
161.0
(147.0 to 171.0)
162.0
(147.0 to 178.0)
Body Surface Area  
Median (Full Range)
Unit of measure:  M^2
Number Analyzed 56 participants 20 participants 35 participants 111 participants
1.72
(1.47 to 2.12)
1.63
(1.48 to 2.05)
1.75
(1.36 to 2.41)
1.72
(1.36 to 2.41)
Albumin  
Median (Full Range)
Unit of measure:  g/dL
Number Analyzed 56 participants 20 participants 35 participants 111 participants
4.1
(3.3 to 4.9)
4.1
(3.6 to 4.8)
4.0
(3.4 to 4.6)
4.1
(3.3 to 4.9)
Number of sites at baseline  
Median (Full Range)
Unit of measure:  Sites
Number Analyzed 56 participants 20 participants 35 participants 111 participants
3.0
(1 to 7)
3.0
(1 to 6)
2.0
(1 to 6)
3.0
(1 to 7)
Time from first diagnosis to registration  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 56 participants 20 participants 35 participants 111 participants
44.0
(0.9 to 170.3)
55.7
(11.5 to 337.3)
47.0
(5.0 to 177.3)
46.5
(0.9 to 337.3)
Time from metastatic disease to registration  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 56 participants 20 participants 35 participants 111 participants
12.5
(0.4 to 129.8)
26.1
(8.4 to 98.2)
13.8
(2.5 to 110.9)
14.8
(0.4 to 129.8)
Time from last progression before study entry  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 56 participants 20 participants 35 participants 111 participants
2.9
(0 to 15.6)
3.2
(0.9 to 14.0)
3.0
(0.7 to 8.1)
3.0
(0.0 to 15.6)
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
40.7
(27.6 to 55.0)
5.0
(0.1 to 24.9)
8.8
(1.9 to 23.7)
2.Primary Outcome
Title Overall Response
Hide Description Overall Response Rate (ORR) in the population evaluable for efficacy according to RECIST v.1.1. ORR was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions; SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; TF, treatment failure.
Time Frame Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Count of Participants
Unit of Measure: Participants
CR
2
   3.7%
0
   0.0%
0
   0.0%
PR
20
  37.0%
1
   5.0%
3
   8.8%
SD
24
  44.4%
9
  45.0%
17
  50.0%
PD
8
  14.8%
10
  50.0%
13
  38.2%
TF
0
   0.0%
0
   0.0%
1
   2.9%
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Responder patients (PR or CR, whichever was first reached)
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 22 1 3
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(3.4 to 12.7)
2.7 [1] 
(NA to NA)
3.6
(2.1 to 16.1)
[1]
Only 1 patient
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A (BRCA+), Cohort A1 (BRCA+/PARPi), Cohort B (Unselected)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0909
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response Rate at 6 Months
Hide Description Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Responder patients
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 22 1 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.1
(31.8 to 74.4)
0 [1] 
(NA to NA)
33.3
(0 to 86.7)
[1]
Only 1 patient
5.Secondary Outcome
Title Duration of Response Rate at 12 Months
Hide Description Duration of response (DoR), defined as the time between the date when the response criteria (PR or CR, whichever was first reached) were fulfilled to the first date when disease progression (PD), recurrence or death was documented. According to the RECIST v.1.1 for target lesions and assessed by MRI: CR, complete response: Disappearance of all target lesions; PD, progressive disease: 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR, partial response: >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Responder patients
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 22 1 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.8
(13.5 to 54.1)
0 [1] 
(NA to NA)
33.3
(0 to 86.7)
[1]
Only 1 patient
6.Secondary Outcome
Title Clinical Benefit Rate
Hide Description

Clinical benefit, defined as the percentage of patients with ORR or SD lasting over three months (SD >3 months).

The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.

SD, stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time Frame Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.1
(46.9 to 74.1)
40.0
(19.1 to 63.9)
32.4
(17.4 to 50.5)
7.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) is defined as the period of time from the date of first infusion to the date of progression disease, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(3.0 to 6.2)
1.4
(1.3 to 3.9)
2.5
(1.3 to 3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A (BRCA+), Cohort A1 (BRCA+/PARPi), Cohort B (Unselected)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Progression-free Survival at 3 Months
Hide Description Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.5
(50.4 to 76.6)
42.5
(20.3 to 64.7)
35.5
(18.9 to 52.1)
9.Secondary Outcome
Title Progression-free Survival at 6 Months
Hide Description Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.6
(24.2 to 50.9)
21.3
(2.8 to 39.7)
11.1
(0 to 22.6)
10.Secondary Outcome
Title Progression-free Survival at 12 Months
Hide Description Progression-free survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.5
(9.1 to 31.9)
0
(0 to 0)
3.7
(0 to 10.7)
11.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Median (95% Confidence Interval)
Unit of Measure: months
18.6
(10.9 to 22.8)
8.1
(4.6 to 14.6)
12.1
(6.6 to 17.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A (BRCA+), Cohort A1 (BRCA+/PARPi), Cohort B (Unselected)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0561
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Overall Survival Rate at 12 Months
Hide Description Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact
Time Frame Time from the date of first infusion to the date of death or last contact, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.5
(49.0 to 75.9)
29.7
(7.9 to 51.5)
55.4
(37.9 to 73.0)
13.Secondary Outcome
Title Overall Survival Rate at 18 Months
Hide Description Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact.
Time Frame Time from the date of first infusion to the date of death or last contact, up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description:
Patients with known deleterious BRCA1/2 mutation status at study entry
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
Overall Number of Participants Analyzed 54 20 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.4
(39.2 to 67.5)
22.3
(1.6 to 42.9)
27.7
(11.5 to 43.9)
Time Frame Participants were assessed through study completion, aproximately 6 years
Adverse Event Reporting Description Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
 
Arm/Group Title Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Hide Arm/Group Description Patients with known deleterious BRCA1/2 mutation status at study entry Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.

Patients without known deleterious BRCA1/2 mutation status at study entry, i.e., either:

  • Patients known to have no deleterious BRCA1/2 mutations (BRCA-), or
  • Patients whose BRCA 1/2 mutation status was unknown (BRCA-UK). BRCA1/2 germline mutation status would be assessed in all patients in this subgroup responding to lurbinectedin treatment.
All-Cause Mortality
Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/54 (74.07%)      13/20 (65.00%)      30/35 (85.71%)    
Hide Serious Adverse Events
Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/54 (25.93%)      5/20 (25.00%)      8/35 (22.86%)    
Blood and lymphatic system disorders       
anaemia  1  2/54 (3.70%)  4 0/20 (0.00%)  0 0/35 (0.00%)  0
Febrile neutropenia  1  7/54 (12.96%)  9 2/20 (10.00%)  2 0/35 (0.00%)  0
Neutropenia  1  2/54 (3.70%)  2 0/20 (0.00%)  0 1/35 (2.86%)  1
Thrombocytopenia  1  6/54 (11.11%)  9 0/20 (0.00%)  0 0/35 (0.00%)  0
Cardiac disorders       
Atrial fibrillation  1  1/54 (1.85%)  2 0/20 (0.00%)  0 0/35 (0.00%)  0
Cardiac failure congestive  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Pericardial effusion  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  2/54 (3.70%)  2 0/20 (0.00%)  0 0/35 (0.00%)  0
Vomiting  1  3/54 (5.56%)  3 0/20 (0.00%)  0 0/35 (0.00%)  0
General disorders       
Catheter site erythema  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Chest discomfort  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Drug interaction  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Hepatobiliary disorders       
Hepatotoxicity  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations       
Myelitis  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Pneumonia  1  2/54 (3.70%)  4 0/20 (0.00%)  0 1/35 (2.86%)  2
Sepsis  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Urinary tract infection  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Staphylococcal bacteraemia  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Listeriosis  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
Septic shock  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications       
Medication error  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Fall  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Investigations       
Neutropenia  1  2/54 (3.70%)  2 0/20 (0.00%)  0 1/35 (2.86%)  1
Alanine aminotransferase increased  1  2/54 (3.70%)  2 0/20 (0.00%)  0 0/35 (0.00%)  0
Aspartate aminotransferase increased  1  2/54 (3.70%)  2 0/20 (0.00%)  0 0/35 (0.00%)  0
Platelet count decreased  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Failure to thrive  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders       
Syncope  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Reproductive system and breast disorders       
Pelvic pain  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/54 (3.70%)  4 1/20 (5.00%)  1 0/35 (0.00%)  0
Epistaxis  1  1/54 (1.85%)  1 0/20 (0.00%)  0 0/35 (0.00%)  0
Pneumonitis  1  1/54 (1.85%)  1 0/20 (0.00%)  0 1/35 (2.86%)  1
Pleural effusion  1  0/54 (0.00%)  0 1/20 (5.00%)  2 0/35 (0.00%)  0
Respiratory failure  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Pulmonary embolism  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
Vascular disorders       
Hypotension  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Jugular vein thrombosis  1  0/54 (0.00%)  0 0/20 (0.00%)  0 1/35 (2.86%)  1
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A (BRCA+) Cohort A1 (BRCA+/PARPi) Cohort B (Unselected)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/54 (100.00%)      20/20 (100.00%)      34/35 (97.14%)    
Blood and lymphatic system disorders       
anaemia  1  13/54 (24.07%)  16 2/20 (10.00%)  3 6/35 (17.14%)  10
febrile neutropenia  1  4/54 (7.41%)  4 0/20 (0.00%)  0 0/35 (0.00%)  0
neutropenia  1  24/54 (44.44%)  48 11/20 (55.00%)  15 7/35 (20.00%)  9
thrombocytopenia  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Cardiac disorders       
tachycardia  1  5/54 (9.26%)  8 1/20 (5.00%)  1 1/35 (2.86%)  1
Endocrine disorders       
Cushingoid  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Eye disorders       
diplopia  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Gastrointestinal disorders       
abdominal pain  1  11/54 (20.37%)  25 5/20 (25.00%)  6 7/35 (20.00%)  12
constipation  1  23/54 (42.59%)  32 9/20 (45.00%)  17 9/35 (25.71%)  17
diarrhoea  1  16/54 (29.63%)  23 4/20 (20.00%)  7 5/35 (14.29%)  6
dyspepsia  1  2/54 (3.70%)  3 1/20 (5.00%)  1 2/35 (5.71%)  3
nausea  1  43/54 (79.63%)  123 15/20 (75.00%)  23 20/35 (57.14%)  37
odynophagia  1  1/54 (1.85%)  1 1/20 (5.00%)  2 1/35 (2.86%)  1
vomiting  1  23/54 (42.59%)  48 7/20 (35.00%)  9 10/35 (28.57%)  13
Gastrooesophageal reflux disease  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
General disorders       
chills  1  1/54 (1.85%)  1 2/20 (10.00%)  2 1/35 (2.86%)  1
fatigue  1  48/54 (88.89%)  195 10/20 (50.00%)  21 30/35 (85.71%)  66
Gait disturbance  1  1/54 (1.85%)  3 0/20 (0.00%)  0 2/35 (5.71%)  2
Influenza like illness  1  3/54 (5.56%)  4 0/20 (0.00%)  0 1/35 (2.86%)  1
Infusion site pain  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Mucosal inflammation  1  13/54 (24.07%)  15 1/20 (5.00%)  1 2/35 (5.71%)  2
Non-cardiac chest pain  1  2/54 (3.70%)  2 1/20 (5.00%)  4 0/35 (0.00%)  0
Oedema  1  5/54 (9.26%)  13 2/20 (10.00%)  2 4/35 (11.43%)  5
pain  1  3/54 (5.56%)  4 0/20 (0.00%)  0 1/35 (2.86%)  1
Pyrexia  1  8/54 (14.81%)  10 4/20 (20.00%)  5 6/35 (17.14%)  16
Chest discomfort  1  0/54 (0.00%)  0 2/20 (10.00%)  3 0/35 (0.00%)  0
Localised oedema  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Hepatomegaly  1  0/54 (0.00%)  0 0/20 (0.00%)  0 3/35 (8.57%)  3
Infections and infestations       
Bronchitis  1  3/54 (5.56%)  3 0/20 (0.00%)  0 1/35 (2.86%)  1
Herpes zoster  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Nasopharyngitis  1  4/54 (7.41%)  5 1/20 (5.00%)  2 1/35 (2.86%)  1
Pharyngitis  1  3/54 (5.56%)  3 0/20 (0.00%)  0 0/35 (0.00%)  0
Sinusitis  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Upper respiratory tract infection  1  2/54 (3.70%)  2 1/20 (5.00%)  1 2/35 (5.71%)  2
Urinary tract infection  1  6/54 (11.11%)  9 1/20 (5.00%)  1 1/35 (2.86%)  1
Candidiasis  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Klebsiella infection  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Staphylococcal bacteraemia  1  0/54 (0.00%)  0 1/20 (5.00%)  2 0/35 (0.00%)  0
Sputum purulent  1  0/54 (0.00%)  0 0/20 (0.00%)  0 2/35 (5.71%)  5
Injury, poisoning and procedural complications       
Fall  1  2/54 (3.70%)  2 1/20 (5.00%)  1 0/35 (0.00%)  0
Lower limb fracture  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Tooth fracture  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Investigations       
Neutropenia  1  24/54 (44.44%)  48 11/20 (55.00%)  15 7/35 (20.00%)  9
Alanine aminotransferase increased  1  3/54 (5.56%)  3 2/20 (10.00%)  5 1/35 (2.86%)  1
Aspartate aminotransferase increased  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Breath sounds abnormal  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/54 (0.00%)  0 1/20 (5.00%)  1 2/35 (5.71%)  2
Weight decreased  1  0/54 (0.00%)  0 2/20 (10.00%)  2 2/35 (5.71%)  2
Platelet count decreased  1  0/54 (0.00%)  0 0/20 (0.00%)  0 2/35 (5.71%)  2
Metabolism and nutrition disorders       
Decreased appetite  1  15/54 (27.78%)  20 6/20 (30.00%)  7 5/35 (14.29%)  9
Dehydration  1  1/54 (1.85%)  1 1/20 (5.00%)  1 1/35 (2.86%)  1
Hypokalaemia  1  1/54 (1.85%)  3 1/20 (5.00%)  3 0/35 (0.00%)  0
Hypomagnesaemia  1  1/54 (1.85%)  1 1/20 (5.00%)  1 2/35 (5.71%)  2
Hyponatraemia  1  0/54 (0.00%)  0 1/20 (5.00%)  1 1/35 (2.86%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/54 (7.41%)  6 4/20 (20.00%)  6 3/35 (8.57%)  3
Back pain  1  7/54 (12.96%)  9 2/20 (10.00%)  5 4/35 (11.43%)  5
Bone pain  1  8/54 (14.81%)  10 2/20 (10.00%)  2 2/35 (5.71%)  2
Musculoskeletal discomfort  1  3/54 (5.56%)  3 0/20 (0.00%)  0 1/35 (2.86%)  1
Musculoskeletal pain  1  9/54 (16.67%)  10 2/20 (10.00%)  2 4/35 (11.43%)  5
Myalgia  1  5/54 (9.26%)  9 0/20 (0.00%)  0 1/35 (2.86%)  1
Neck pain  1  2/54 (3.70%)  2 0/20 (0.00%)  0 2/35 (5.71%)  2
Pain in extremity  1  6/54 (11.11%)  8 0/20 (0.00%)  0 1/35 (2.86%)  2
Pain in jaw  1  1/54 (1.85%)  1 1/20 (5.00%)  2 1/35 (2.86%)  1
Nervous system disorders       
Dizziness  1  7/54 (12.96%)  9 2/20 (10.00%)  3 3/35 (8.57%)  4
Dysgeusia  1  3/54 (5.56%)  8 2/20 (10.00%)  2 0/35 (0.00%)  0
Headache  1  16/54 (29.63%)  29 6/20 (30.00%)  10 5/35 (14.29%)  5
Neuralgia  1  1/54 (1.85%)  2 1/20 (5.00%)  1 1/35 (2.86%)  1
Neuropathy peripheral  1  6/54 (11.11%)  6 1/20 (5.00%)  1 2/35 (5.71%)  2
Tremor  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Psychiatric disorders       
Anxiety  1  8/54 (14.81%)  9 0/20 (0.00%)  0 2/35 (5.71%)  2
Depression  1  3/54 (5.56%)  3 0/20 (0.00%)  0 2/35 (5.71%)  2
Insomnia  1  4/54 (7.41%)  4 2/20 (10.00%)  2 1/35 (2.86%)  1
Renal and urinary disorders       
Dysuria  1  1/54 (1.85%)  1 0/20 (0.00%)  0 2/35 (5.71%)  2
Pollakiuria  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Reproductive system and breast disorders       
Breast pain  1  2/54 (3.70%)  2 1/20 (5.00%)  1 0/35 (0.00%)  0
Pelvic pain  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  16/54 (29.63%)  21 2/20 (10.00%)  2 6/35 (17.14%)  9
Dyspnoea  1  11/54 (20.37%)  12 5/20 (25.00%)  11 8/35 (22.86%)  12
Nasal congestion  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Oropharyngeal pain  1  1/54 (1.85%)  1 1/20 (5.00%)  1 0/35 (0.00%)  0
Pleural effusion  1  1/54 (1.85%)  1 0/20 (0.00%)  0 2/35 (5.71%)  2
Pulmonary embolism  1  0/54 (0.00%)  0 1/20 (5.00%)  1 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  3/54 (5.56%)  3 0/20 (0.00%)  0 0/35 (0.00%)  0
Dry skin  1  4/54 (7.41%)  4 0/20 (0.00%)  0 2/35 (5.71%)  2
Erythema  1  3/54 (5.56%)  3 0/20 (0.00%)  0 1/35 (2.86%)  1
Pruritus  1  1/54 (1.85%)  1 0/20 (0.00%)  0 2/35 (5.71%)  2
Rash  1  8/54 (14.81%)  10 1/20 (5.00%)  1 2/35 (5.71%)  2
Skin hyperpigmentation  1  2/54 (3.70%)  2 1/20 (5.00%)  1 1/35 (2.86%)  1
Vascular disorders       
Deep vein thrombosis  1  2/54 (3.70%)  2 1/20 (5.00%)  1 1/35 (2.86%)  1
Hot flush  1  1/54 (1.85%)  1 1/20 (5.00%)  2 0/35 (0.00%)  0
Hypotension  1  1/54 (1.85%)  1 2/20 (10.00%)  2 2/35 (5.71%)  2
Lymphoedema  1  4/54 (7.41%)  5 0/20 (0.00%)  0 4/35 (11.43%)  5
Phlebitis  1  4/54 (7.41%)  5 2/20 (10.00%)  3 2/35 (5.71%)  2
Flushing  1  0/54 (0.00%)  0 1/20 (5.00%)  1 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
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.
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 less than or equal to 60 days from the time submitted to the sponsor for review
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pharma Mar S.A.
Organization: Pharma Mar S.A.
Phone: 00 34 91846 60 00
EMail: clinicaltrials@pharmamar.com
Layout table for additonal information
Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT01525589    
Other Study ID Numbers: PM1183-B-003-11
First Submitted: January 30, 2012
First Posted: February 3, 2012
Results First Submitted: July 20, 2020
Results First Posted: September 25, 2020
Last Update Posted: September 25, 2020