Trial Outcomes & Findings for Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors (NCT NCT05063318)
NCT ID: NCT05063318
Last Updated: 2025-09-02
Results Overview
The primary parameter of interest for the statistical analysis will be plasma dose adjusted AUC(0-∞)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)
Results posted on
2025-09-02
Participant Flow
14 patients were included and treated at 2 sites: 3 in Part A in Sequence 1 (S1 TR: ITZ+lurbinectedin in Cycle 1) and 11 in Part B, of them 5 in S1 and 6 in Sequence 2 (S2 RT: ITZ+lurbinectedin in Cycle 2). In Part A, all patients were assigned to S1 TR, while in Part B, patients were randomly assigned at a 1:1 ratio to S1 TR or S2 RT. Patients participated between 7Oct2020 and 3Mar2022 (last follow-up). The 1st dose of the 1st cycle on 15Oct2020. The last dose of the last cycle on 7Feb2022.
Participant milestones
| Measure |
Part A - S1 (TR)
PART A The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m². In Part A, all patients will receive itraconazole plus lurbinectedin in Cycle 1 and lurbinectedin alone in Cycles 2 and 3 (this last cycle being optional).
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S1 (TR)
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S2 (RT)
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 2 (RT):
* Cycle 1: Lurbinectedin alone 3.2 mg/m²
* Cycle 2: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional) Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
6
|
Reasons for withdrawal
| Measure |
Part A - S1 (TR)
PART A The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m². In Part A, all patients will receive itraconazole plus lurbinectedin in Cycle 1 and lurbinectedin alone in Cycles 2 and 3 (this last cycle being optional).
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S1 (TR)
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S2 (RT)
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 2 (RT):
* Cycle 1: Lurbinectedin alone 3.2 mg/m²
* Cycle 2: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional) Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.
|
|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
0
|
3
|
|
Overall Study
Compassionate use
|
1
|
3
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part A - S1 (TR)
n=3 Participants
PART A The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m². In Part A, all patients will receive itraconazole plus lurbinectedin in Cycle 1 and lurbinectedin alone in Cycles 2 and 3 (this last cycle being optional).
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S1 (TR)
n=5 Participants
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 1 (TR)
* Cycle 1: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 2: Lurbinectedin alone 3.2 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional)
Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A
|
Part B - S2 (RT)
n=6 Participants
PART B Randomization will apply for study Part B only. In Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. In Part B, patients will be randomly assigned to the corresponding sequences.
Sequence 2 (RT):
* Cycle 1: Lurbinectedin alone 3.2 mg/m²
* Cycle 2: Itraconazole + lurbinectedin 0.8 mg/m²
* Cycle 3: Lurbinectedin alone 3.2 mg/m² (optional) Lurbinectedin alone: The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
Lurbinectedin+Itraconazole co-administration: The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.
|
Total
n=14 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
64 years
n=7 Participants
|
62 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
ECOG PS
0
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
ECOG PS
1
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Weight
|
58.9 kg
n=5 Participants
|
66.6 kg
n=7 Participants
|
69.5 kg
n=5 Participants
|
67.5 kg
n=4 Participants
|
|
Height
|
165 cm
n=5 Participants
|
163 cm
n=7 Participants
|
166.5 cm
n=5 Participants
|
165 cm
n=4 Participants
|
|
Stage at diagnosis
Early
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Stage at diagnosis
Locally advanced
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Stage at diagnosis
Metastatic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Primary tumor
Ovarian carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Primary tumor
Lung
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Primary tumor
Endometrial carcinoma
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Primary tumor
Colon adenocarcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary tumor
Epidermoid carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary tumor
Leiomyosarcoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary tumor
Mesothelioma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary tumor
Pancreatobiliary adenocarcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Number of sites at baseline
|
4 sites
n=5 Participants
|
3 sites
n=7 Participants
|
2 sites
n=5 Participants
|
3 sites
n=4 Participants
|
|
Sites at baseline
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sites at baseline
2
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sites at baseline
3
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sites at baseline
>4
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Time from diagnosis to first infusion
|
2.6 years
n=5 Participants
|
3.4 years
n=7 Participants
|
3.5 years
n=5 Participants
|
3.4 years
n=4 Participants
|
|
Prior surgery
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Prior radiotherapy
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Number of prior lines
|
4 lines
n=5 Participants
|
3 lines
n=7 Participants
|
6 lines
n=5 Participants
|
4 lines
n=4 Participants
|
|
Prior lines
2 lines
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Prior lines
3 lines
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Prior lines
≥4 lines
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Number of prior chemotherapy lines
|
2 Lines of chemotherapy
n=5 Participants
|
3 Lines of chemotherapy
n=7 Participants
|
5 Lines of chemotherapy
n=5 Participants
|
4 Lines of chemotherapy
n=4 Participants
|
|
Prior chemotherapy lines
2 lines
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Prior chemotherapy lines
3 lines
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Prior chemotherapy lines
≥4 lines
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction. Part A was meant to ensure the adequacy of the dose of lurbinectedin (0.8 mg/m²) when given in combination with itraconazole, and patients (n=3) were not randomized for treatment sequence, so they were not included in the main analysis, as pre-specified in protocol.
The primary parameter of interest for the statistical analysis will be plasma dose adjusted AUC(0-∞)
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: Dose-adjusted AUC(0-∞)
|
288.55 μg·h/L/mg
Geometric Coefficient of Variation 73.9
|
105.8 μg·h/L/mg
Geometric Coefficient of Variation 77.37
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction
The dose-normalized area under the concentration-time curve (AUC) will be calculated using the linear-log trapezoidal rule with extrapolation to infinity.
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: Dose-normalized AUC(0-t)
|
244.77 μg·h/L/mg
Geometric Coefficient of Variation 91.89
|
103.4 μg·h/L/mg
Geometric Coefficient of Variation 78.85
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction
The maximum dose-normalized plasma concentration (Cmax) will be obtained directly from the experimental data.
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: Dose-normalized Cmax
|
25.91 μg/L/mg
Geometric Coefficient of Variation 53.15
|
22.43 μg/L/mg
Geometric Coefficient of Variation 53.75
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction
Terminal half-life (T1/2) will be obtained from the terminal rate constant calculated by linear regression using at least 3 observations.
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: T1/2
|
101.36 hours
Geometric Coefficient of Variation 61
|
46.59 hours
Geometric Coefficient of Variation 17.12
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction
Total body clearance (CL), calculated by dividing the administered dose by the AUC with extrapolation to infinity.
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: Total Body Clearance (CL)
|
3.47 L/h
Geometric Coefficient of Variation 73.9
|
9.45 L/h
Geometric Coefficient of Variation 77.37
|
SECONDARY outcome
Timeframe: Day 1, 2, 3, 5, 8, 11, 15, 22 (Cycle 1,2,3) (each cycle is 21 days)Population: The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction
Volume of distribution (both at steady state and based on the terminal phase) (Vss and Vz, respectively): Vss is an estimate that equals mean residence time times total body clearance. Vz, calculated dividing the administered dose by the product of the AUC with extrapolation to infinity by the terminal rate constant
Outcome measures
| Measure |
ITZ+LRB
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the ITZ - lurbinectedin drug-drug interaction.
|
LRB Alone
n=8 Participants
The pharmacokinetic analysis included data from only PK - evaluable patients from study Part B and the same study population was used to perform the statistical analysis in evaluating the lurbinectedin alone.
|
|---|---|---|
|
Pharmacokinetic Analysis: Volume of Distribution
|
418.68 L
Geometric Coefficient of Variation 111.45
|
419.14 L
Geometric Coefficient of Variation 58.58
|
Adverse Events
ITZ+LRB Cycle
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
LRB Alone Cycle
Serious events: 5 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ITZ+LRB Cycle
n=13 participants at risk
The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A was 0.8 mg/m², and in Part B was susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. Patients treated in Part A were not evaluable for PK but were evaluable for safety. For that reason, this arm is reported in the safety section but not in the PK section.
|
LRB Alone Cycle
n=14 participants at risk
The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 2 • Three 21-days cycles
|
7.1%
1/14 • Number of events 2 • Three 21-days cycles
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.7%
1/13 • Number of events 2 • Three 21-days cycles
|
7.1%
1/14 • Number of events 2 • Three 21-days cycles
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
Other adverse events
| Measure |
ITZ+LRB Cycle
n=13 participants at risk
The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A was 0.8 mg/m², and in Part B was susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A. Patients treated in Part A were not evaluable for PK but were evaluable for safety. For that reason, this arm is reported in the safety section but not in the PK section.
|
LRB Alone Cycle
n=14 participants at risk
The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
53.8%
7/13 • Number of events 13 • Three 21-days cycles
|
50.0%
7/14 • Number of events 13 • Three 21-days cycles
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
4/13 • Number of events 7 • Three 21-days cycles
|
28.6%
4/14 • Number of events 7 • Three 21-days cycles
|
|
General disorders
Fatigue
|
30.8%
4/13 • Number of events 6 • Three 21-days cycles
|
28.6%
4/14 • Number of events 6 • Three 21-days cycles
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 2 • Three 21-days cycles
|
7.1%
1/14 • Number of events 2 • Three 21-days cycles
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Number of events 2 • Three 21-days cycles
|
7.1%
1/14 • Number of events 2 • Three 21-days cycles
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 10 • Three 21-days cycles
|
35.7%
5/14 • Number of events 10 • Three 21-days cycles
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Infections and infestations
Stoma site infection
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.7%
1/13 • Number of events 1 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • Three 21-days cycles
|
7.1%
1/14 • Number of events 1 • Three 21-days cycles
|
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