Trial Outcomes & Findings for Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors (NCT NCT05072106)
NCT ID: NCT05072106
Last Updated: 2025-09-16
Results Overview
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)
Results posted on
2025-09-16
Participant Flow
11 patients were included/treated at 2 sites: 7 in Sequence 1 (TR: Test-Reference; bosentan+lurbinectedin in Cycle 1) and 4 in Sequence 2 (RT: Reference-Test; bosentan+lurbinectedin in Cycle 2). Patients participated between 14 Jan 2021 and 22 Dec 2021. The 1st dose of the 1st cycle was given on 25 Jan 2021 and the last dose of the last cycle on 25 Nov 2021
Participant milestones
| Measure |
Sequence 1 (TR: Test-Reference)
Patients received two consecutive cycles of lurbinectedin, the first one with bosentan co-administration and the second one lurbinectedin alone, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit).
|
Sequence 2 (RT: Refence-Test)
Patients received two consecutive cycles of lurbinectedin, the first one lurbinectedin alone and the second one with bosentan co-administration, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Sequence 1 (TR: Test-Reference)
Patients received two consecutive cycles of lurbinectedin, the first one with bosentan co-administration and the second one lurbinectedin alone, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit).
|
Sequence 2 (RT: Refence-Test)
Patients received two consecutive cycles of lurbinectedin, the first one lurbinectedin alone and the second one with bosentan co-administration, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit)
|
|---|---|---|
|
Overall Study
Progressive disease
|
3
|
3
|
|
Overall Study
Compassionate use
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Sequence 1 (TR: Test-Reference)
n=7 Participants
Patients received two consecutive cycles of lurbinectedin, the first one with bosentan co-administration and the second one lurbinectedin alone, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit).
|
Sequence 2 (RT: Refence-Test)
n=4 Participants
Patients received two consecutive cycles of lurbinectedin, the first one lurbinectedin alone and the second one with bosentan co-administration, followed by a third cycle with lurbinectedin alone (this last was optional for patients with clinical benefit)
|
Total
n=11 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
60 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Weight
|
66.4 kg
n=5 Participants
|
72.4 kg
n=7 Participants
|
66.4 kg
n=5 Participants
|
|
Height
|
163 cm
n=5 Participants
|
174.5 cm
n=7 Participants
|
168 cm
n=5 Participants
|
|
Body Surface Area
|
1.7 square metre
n=5 Participants
|
1.9 square metre
n=7 Participants
|
1.7 square metre
n=5 Participants
|
|
ECOG PS
PS 0
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
ECOG PS
PS 1
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Stage at diagnosis
Early
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Stage at diagnosis
Locally advanced
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Stage at diagnosis
Metastatic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary tumor site
Lung
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary tumor site
Ovarian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Primary tumor site
Breast
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor site
Cervical
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor site
Colon
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor site
Gall bladder
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor site
Mesothelioma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor site
Neuroendocrine tumor
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of disease sites at baseline
|
3 sites
n=5 Participants
|
6 sites
n=7 Participants
|
3 sites
n=5 Participants
|
|
Time from diagnosis to first infusion
|
47.7 months
n=5 Participants
|
13.7 months
n=7 Participants
|
47.3 months
n=5 Participants
|
|
Prior surgery
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Prior radiotherapy
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of prior Anticancer Therapy lines
|
5 lines
n=5 Participants
|
2.5 lines
n=7 Participants
|
4 lines
n=5 Participants
|
|
Number of prior chemotherapy lines
|
3 lines
n=5 Participants
|
2.5 lines
n=7 Participants
|
3 lines
n=5 Participants
|
PRIMARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for Pharmacokinetic (PK) assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Total Lurbinectedin: Alone and in Combination With Bosentan.
|
20.71 μg/L/mg
Geometric Coefficient of Variation 54.81
|
21.39 μg/L/mg
Geometric Coefficient of Variation 49.56
|
PRIMARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Extrapolated Infinity (AUC0-∞) of Total Lurbinectedin: Alone and in Combination With Bosentan
|
58.83 μg·h/L/mg
Geometric Coefficient of Variation 75.83
|
73.71 μg·h/L/mg
Geometric Coefficient of Variation 86.93
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total Lurbinectedin: Alone and in Combination With Bosentan
|
56.33 μg·h/L/mg
Geometric Coefficient of Variation 76.47
|
71.13 μg·h/L/mg
Geometric Coefficient of Variation 84.97
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Plasma Clearance (CL) of Total Lurbinectedin: Alone and in Combination With Bosentan
|
17.00 L/h
Geometric Coefficient of Variation 75.83
|
13.57 L/h
Geometric Coefficient of Variation 86.93
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Plasma Volume of Distribution at Steady-state (Vss) of Total Lurbinectedin: Alone and in Combination With Bosentan
|
412.94 L
Geometric Coefficient of Variation 78.11
|
386.69 L
Geometric Coefficient of Variation 65.5
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) in Plasma of Total Lurbinectedin: Alone and in Combination With Bosentan
|
35.51 h
Geometric Coefficient of Variation 61.54
|
33.84 h
Geometric Coefficient of Variation 35.26
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Unbound Lurbinectedin: Alone and in Combination With Bosentan
|
0.0324 μg/L/mg
Geometric Coefficient of Variation 51.77
|
0.0332 μg/L/mg
Geometric Coefficient of Variation 19.18
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Extrapolated Infinity (AUC0-∞) of Unbound Lurbinectedin: Alone and in Combination With Bosentan
|
0.095 μg·h/L/mg
Geometric Coefficient of Variation 73.04
|
0.114 μg·h/L/mg
Geometric Coefficient of Variation 61.09
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Last Quantifiable Concentration (AUC0-t) of Unbound Plasma Lurbinectedin: Alone and in Combination With Bosentan
|
0.0907 μg·h/L/mg
Geometric Coefficient of Variation 72.73
|
0.1099 μg·h/L/mg
Geometric Coefficient of Variation 58.24
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Plasma Clearance (CL) of Unbound Lurbinectedin: Alone and in Combination With Bosentan
|
10530.93 L/h
Geometric Coefficient of Variation 73.04
|
8773.36 L/h
Geometric Coefficient of Variation 61.09
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Plasma Volume of Distribution at Steady-state (Vss) of Unbound Lurbinectedin: Alone and in Combination With Bosentan
|
266905.87 L
Geometric Coefficient of Variation 73.09
|
241282.16 L
Geometric Coefficient of Variation 23.18
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7, 25, 49, 97 and 169 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2 and two patients were excluded due to extremely high unbound fraction values
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=6 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=6 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) in Plasma of Unbound Lurbinectedin: Alone and in Combination With Bosentan
|
37.41 h
Geometric Coefficient of Variation 73.98
|
32.33 h
Geometric Coefficient of Variation 39.36
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7 and 25 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2. For 1 patient all PK samples for M1 in lurbinectedin alone cycle were below the limit of quantification
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=7 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Total Lurbinectedin Metabolite M1: Alone and in Combination With Bosentan
|
0.3849 μg/L/mg
Geometric Coefficient of Variation 92.13
|
0.268 μg/L/mg
Geometric Coefficient of Variation 78.43
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7 and 25 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2. For 1 patient all PK samples for M1 in lurbinectedin alone cycle were below the limit of quantification
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=7 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total Lurbinectedin Metabolite M1: Alone and in Combination With Bosentan
|
0.728 μg·h/L/mg
Geometric Coefficient of Variation 236.22
|
0.6916 μg·h/L/mg
Geometric Coefficient of Variation 114.55
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7 and 25 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Total Lurbinectedin Metabolite M4: Alone and in Combination With Bosentan
|
0.5617 μg/L/mg
Geometric Coefficient of Variation 103.28
|
0.5528 μg/L/mg
Geometric Coefficient of Variation 101.15
|
SECONDARY outcome
Timeframe: Preinfusion, 0.917, 1.5, 2, 3, 5, 7 and 25 hours post lurbinectedin infusion start on Day 1 of Cycle 1 or Cycle 2 (each cycle is 21 days)Population: Three treated patients were not evaluable for PK assessments due to lack of treatment at Cycle 2
Pharmacokinetic analyses will be evaluated in plasma by standard non-compartmental methods, or population methods, if necessary.
Outcome measures
| Measure |
Bosentan Co-administration Cycle
n=8 Participants
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 Participants
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Dose-normalized Area Under the Plasma Concentration-time Profile From Time Zero to Last Quantifiable Concentration (AUC0-t) of Total Lurbinectedin Metabolite M4: Alone and in Combination With Bosentan
|
0.9962 μg·h/L/mg
Geometric Coefficient of Variation 267.9
|
1.382 μg·h/L/mg
Geometric Coefficient of Variation 390.96
|
Adverse Events
Bosentan Co-administration Cycle
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Single Agent Lurbinectedin Cycle
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bosentan Co-administration Cycle
n=11 participants at risk
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1. Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 participants at risk
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Nervous system disorders
Monoparesis
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Oesophagitis
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Product Issues
Thrombosis in device
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
12.5%
1/8 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
Other adverse events
| Measure |
Bosentan Co-administration Cycle
n=11 participants at risk
* Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
* Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1 in first three patients. Dose for remaining five patients will depend on PK and safety outcomes in first three patients.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1. Bosentan: Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
|
Single Agent Lurbinectedin Cycle
n=8 participants at risk
3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
Lurbinectedin: 3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
|
|---|---|---|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/11 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
12.5%
1/8 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
25.0%
2/8 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Nervous system disorders
Monoparesis
|
9.1%
1/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 7 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
General disorders
Pain
|
0.00%
0/11 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
12.5%
1/8 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
12.5%
1/8 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
1/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 3 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
12.5%
1/8 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 2 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
0.00%
0/8 • From 14 January 2021 to 18 January 2022 (1 year). Adverse events will be monitored from first administration date to the end of the follow-up period which corresponds to the visit of the end of treatment (EOT), calculated as 31 days (±10 days) after the last lurbinectedin infusion or until the patient starts a new antitumor therapy or until the date of death, whichever occurs first
|
Additional Information
Clinical Developtment, Department of PharmaMar's Oncology, Business Unit,
Pharma Mar S.A.
Phone: 0034918466000
Email: [email protected]
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 more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER