Trial Outcomes & Findings for A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer (NCT NCT01525589)
NCT ID: NCT01525589
Last Updated: 2020-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Results posted on
2020-09-25
Participant Flow
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).
Participant milestones
| Measure |
Cohort A (BRCA+)
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
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 Study
STARTED
|
56
|
20
|
35
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
56
|
20
|
35
|
Reasons for withdrawal
| Measure |
Cohort A (BRCA+)
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
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 Study
Non-treatment-related AE
|
1
|
0
|
0
|
|
Overall Study
Progressive disease
|
48
|
15
|
29
|
|
Overall Study
Never treated
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
4
|
2
|
2
|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Treatment-related AE
|
1
|
1
|
2
|
|
Overall Study
Other reasons
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (BRCA+)
n=56 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=35 Participants
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
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
42.5 years
n=5 Participants
|
45.0 years
n=7 Participants
|
52.0 years
n=5 Participants
|
45.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
50 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
21 participants
n=5 Participants
|
4 participants
n=7 Participants
|
26 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
ECOG PS
PS 0
|
32 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
ECOG PS
PS 1
|
24 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sites of disease at diagnosis
Left breast
|
26 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sites of disease at diagnosis
Right breast
|
28 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sites of disease at diagnosis
Bilateral
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Histology type at diagnosis
Ductal carcinoma
|
54 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Histology type at diagnosis
Lobular carcinoma
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Histology type at diagnosis
Lobular and ductal carcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Histology grade at diagnosis
Well differentiated
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Histology grade at diagnosis
Moderately differentiated
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Histology grade at diagnosis
Poorly differentiated
|
31 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Histology grade at diagnosis
Unknown
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Stage at diagnosis
Stage I
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Stage at diagnosis
Stage II
|
26 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Stage at diagnosis
Stage III
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Stage at diagnosis
Stage IV
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
BRCA deleterious mutation
BRCA1
|
33 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
BRCA deleterious mutation
BRCA2
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
BRCA deleterious mutation
Both
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
BRCA deleterious mutation
Not applicable
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Hormonal status
Triple negative
|
33 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Hormonal status
ER and/or PR positive and HER2 negative
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Hormonal status
ER and/or PR positive and HER2 positive
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Hormonal status
ER and PR negative and HER2 positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sites at baseline
<3 sites
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sites at baseline
≥3 sites
|
33 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Prior surgery
|
53 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Prior radiotherapy
|
44 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Weight
|
69.2 Kg
n=5 Participants
|
59.8 Kg
n=7 Participants
|
71.7 Kg
n=5 Participants
|
68.1 Kg
n=4 Participants
|
|
Height
|
162.5 cm
n=5 Participants
|
161.0 cm
n=7 Participants
|
161.0 cm
n=5 Participants
|
162.0 cm
n=4 Participants
|
|
Body Surface Area
|
1.72 m^2
n=5 Participants
|
1.63 m^2
n=7 Participants
|
1.75 m^2
n=5 Participants
|
1.72 m^2
n=4 Participants
|
|
Albumin
|
4.1 g/dL
n=5 Participants
|
4.1 g/dL
n=7 Participants
|
4.0 g/dL
n=5 Participants
|
4.1 g/dL
n=4 Participants
|
|
Number of sites at baseline
|
3.0 sites
n=5 Participants
|
3.0 sites
n=7 Participants
|
2.0 sites
n=5 Participants
|
3.0 sites
n=4 Participants
|
|
Time from first diagnosis to registration
|
44.0 months
n=5 Participants
|
55.7 months
n=7 Participants
|
47.0 months
n=5 Participants
|
46.5 months
n=4 Participants
|
|
Time from metastatic disease to registration
|
12.5 months
n=5 Participants
|
26.1 months
n=7 Participants
|
13.8 months
n=5 Participants
|
14.8 months
n=4 Participants
|
|
Time from last progression before study entry
|
2.9 weeks
n=5 Participants
|
3.2 weeks
n=7 Participants
|
3.0 weeks
n=5 Participants
|
3.0 weeks
n=4 Participants
|
PRIMARY outcome
Timeframe: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollmentPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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 Response Rate (ORR)
|
40.7 percentage
Interval 27.6 to 55.0
|
5.0 percentage
Interval 0.1 to 24.9
|
8.8 percentage
Interval 1.9 to 23.7
|
PRIMARY outcome
Timeframe: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollmentPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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 Response
CR
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response
PR
|
20 Participants
|
1 Participants
|
3 Participants
|
|
Overall Response
SD
|
24 Participants
|
9 Participants
|
17 Participants
|
|
Overall Response
PD
|
8 Participants
|
10 Participants
|
13 Participants
|
|
Overall Response
TF
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollmentPopulation: Responder patients (PR or CR, whichever was first reached)
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=22 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=1 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=3 Participants
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.
|
|---|---|---|---|
|
Duration of Response
|
6.3 months
Interval 3.4 to 12.7
|
2.7 months
Only 1 patient
|
3.6 months
Interval 2.1 to 16.1
|
SECONDARY outcome
Timeframe: Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 6 monthsPopulation: Responder patients
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=22 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=1 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=3 Participants
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.
|
|---|---|---|---|
|
Duration of Response Rate at 6 Months
|
53.1 percentage of participants
Interval 31.8 to 74.4
|
0 percentage of participants
Only 1 patient
|
33.3 percentage of participants
Interval 0.0 to 86.7
|
SECONDARY outcome
Timeframe: Time between the response criteria date and the date when disease progression, recurrence or death was documented, up to 12 monthsPopulation: Responder patients
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=22 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=1 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=3 Participants
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.
|
|---|---|---|---|
|
Duration of Response Rate at 12 Months
|
33.8 percentage of participants
Interval 13.5 to 54.1
|
0 percentage of participants
Only 1 patient
|
33.3 percentage of participants
Interval 0.0 to 86.7
|
SECONDARY outcome
Timeframe: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollmentPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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.
|
|---|---|---|---|
|
Clinical Benefit Rate
|
61.1 percentage of participants
Interval 46.9 to 74.1
|
40.0 percentage of participants
Interval 19.1 to 63.9
|
32.4 percentage of participants
Interval 17.4 to 50.5
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.6 months
Interval 3.0 to 6.2
|
1.4 months
Interval 1.3 to 3.9
|
2.5 months
Interval 1.3 to 3.4
|
SECONDARY outcome
Timeframe: Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 3 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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.
|
|---|---|---|---|
|
Progression-free Survival at 3 Months
|
63.5 percentage of participants
Interval 50.4 to 76.6
|
42.5 percentage of participants
Interval 20.3 to 64.7
|
35.5 percentage of participants
Interval 18.9 to 52.1
|
SECONDARY outcome
Timeframe: Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 6 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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.
|
|---|---|---|---|
|
Progression-free Survival at 6 Months
|
37.6 percentage of participants
Interval 24.2 to 50.9
|
21.3 percentage of participants
Interval 2.8 to 39.7
|
11.1 percentage of participants
Interval 0.0 to 22.6
|
SECONDARY outcome
Timeframe: Time from the date of first infusion to the date of PD, death (due to any cause), or last tumor evaluation, up to 12 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
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.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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.
|
|---|---|---|---|
|
Progression-free Survival at 12 Months
|
20.5 percentage of participants
Interval 9.1 to 31.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
3.7 percentage of participants
Interval 0.0 to 10.7
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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 Survival (OS)
|
18.6 months
Interval 10.9 to 22.8
|
8.1 months
Interval 4.6 to 14.6
|
12.1 months
Interval 6.6 to 17.9
|
SECONDARY outcome
Timeframe: Time from the date of first infusion to the date of death or last contact, up to 12 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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 Survival Rate at 12 Months
|
62.5 percentage of participants
Interval 49.0 to 75.9
|
29.7 percentage of participants
Interval 7.9 to 51.5
|
55.4 percentage of participants
Interval 37.9 to 73.0
|
SECONDARY outcome
Timeframe: Time from the date of first infusion to the date of death or last contact, up to 18 monthsPopulation: Cohort A: Two patients never treated; Cohort B: 1 patient due to lack of post-baseline tumor assessments
Overall survival (OS), defined as the time from the date of first infusion to the date of death or last contact.
Outcome measures
| Measure |
Cohort A (BRCA+)
n=54 Participants
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 Participants
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=34 Participants
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 Survival Rate at 18 Months
|
53.4 percentage of participants
Interval 39.2 to 67.5
|
22.3 percentage of participants
Interval 1.6 to 42.9
|
27.7 percentage of participants
Interval 11.5 to 43.9
|
Adverse Events
Cohort A (BRCA+)
Serious events: 14 serious events
Other events: 54 other events
Deaths: 40 deaths
Cohort A1 (BRCA+/PARPi)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 13 deaths
Cohort B (Unselected)
Serious events: 8 serious events
Other events: 34 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Cohort A (BRCA+)
n=54 participants at risk
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 participants at risk
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=35 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
3.7%
2/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.0%
7/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
6/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Cardiac disorders
Pericardial effusion
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Catheter site erythema
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Chest discomfort
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Drug interaction
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Myelitis
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Pneumonia
|
3.7%
2/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Listeriosis
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Septic shock
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Injury, poisoning and procedural complications
Medication error
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Neutropenia
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Platelet count decreased
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
2/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Syncope
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Hypotension
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
Other adverse events
| Measure |
Cohort A (BRCA+)
n=54 participants at risk
Patients with known deleterious BRCA1/2 mutation status at study entry
|
Cohort A1 (BRCA+/PARPi)
n=20 participants at risk
Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.
|
Cohort B (Unselected)
n=35 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
42.6%
23/54 • Number of events 32 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
45.0%
9/20 • Number of events 17 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
25.7%
9/35 • Number of events 17 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
diarrhoea
|
29.6%
16/54 • Number of events 23 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
4/20 • Number of events 7 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
14.3%
5/35 • Number of events 6 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
dyspepsia
|
3.7%
2/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
nausea
|
79.6%
43/54 • Number of events 123 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
75.0%
15/20 • Number of events 23 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
57.1%
20/35 • Number of events 37 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
odynophagia
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
vomiting
|
42.6%
23/54 • Number of events 48 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
35.0%
7/20 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
28.6%
10/35 • Number of events 13 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
chills
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
fatigue
|
88.9%
48/54 • Number of events 195 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
50.0%
10/20 • Number of events 21 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
85.7%
30/35 • Number of events 66 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Gait disturbance
|
1.9%
1/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Influenza like illness
|
5.6%
3/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Infusion site pain
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Mucosal inflammation
|
24.1%
13/54 • Number of events 15 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Non-cardiac chest pain
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Oedema
|
9.3%
5/54 • Number of events 13 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
11.4%
4/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
anaemia
|
24.1%
13/54 • Number of events 16 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
17.1%
6/35 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
7.4%
4/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
neutropenia
|
44.4%
24/54 • Number of events 48 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
55.0%
11/20 • Number of events 15 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
7/35 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Cardiac disorders
tachycardia
|
9.3%
5/54 • Number of events 8 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Eye disorders
diplopia
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Gastrointestinal disorders
abdominal pain
|
20.4%
11/54 • Number of events 25 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
25.0%
5/20 • Number of events 6 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
7/35 • Number of events 12 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
pain
|
5.6%
3/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Pyrexia
|
14.8%
8/54 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
4/20 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
17.1%
6/35 • Number of events 16 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Chest discomfort
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
General disorders
Localised oedema
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
8.6%
3/35 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Bronchitis
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Herpes zoster
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
4/54 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Pharyngitis
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Urinary tract infection
|
11.1%
6/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Candidiasis
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Neutropenia
|
44.4%
24/54 • Number of events 48 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
55.0%
11/20 • Number of events 15 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
7/35 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Weight decreased
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Investigations
Platelet count decreased
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.8%
15/54 • Number of events 20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
30.0%
6/20 • Number of events 7 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
14.3%
5/35 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
4/54 • Number of events 6 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
20.0%
4/20 • Number of events 6 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
8.6%
3/35 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
7/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
11.4%
4/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.8%
8/54 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
9/54 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
11.4%
4/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
5/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
6/54 • Number of events 8 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Dizziness
|
13.0%
7/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
8.6%
3/35 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Dysgeusia
|
5.6%
3/54 • Number of events 8 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Headache
|
29.6%
16/54 • Number of events 29 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
30.0%
6/20 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
14.3%
5/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Neuralgia
|
1.9%
1/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Neuropathy peripheral
|
11.1%
6/54 • Number of events 6 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Nervous system disorders
Tremor
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Psychiatric disorders
Anxiety
|
14.8%
8/54 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Psychiatric disorders
Depression
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Psychiatric disorders
Insomnia
|
7.4%
4/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Renal and urinary disorders
Pollakiuria
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Reproductive system and breast disorders
Breast pain
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.6%
16/54 • Number of events 21 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
17.1%
6/35 • Number of events 9 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.4%
11/54 • Number of events 12 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
25.0%
5/20 • Number of events 11 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
22.9%
8/35 • Number of events 12 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
4/54 • Number of events 4 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
3/54 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
8/54 • Number of events 10 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
2/54 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
2.9%
1/35 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Hot flush
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Hypotension
|
1.9%
1/54 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Lymphoedema
|
7.4%
4/54 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/20 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
11.4%
4/35 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Phlebitis
|
7.4%
4/54 • Number of events 5 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
10.0%
2/20 • Number of events 3 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.7%
2/35 • Number of events 2 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Vascular disorders
Flushing
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/54 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
5.0%
1/20 • Number of events 1 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
0.00%
0/35 • Participants were assessed through study completion, aproximately 6 years
Two patients in Cohort A were never treated with lurbinectedin and therefore were not included in the analysis of safety
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER