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Trial Outcomes & Findings for Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (NCT NCT02454972)

NCT ID: NCT02454972

Last Updated: 2023-03-02

Results Overview

Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

345 participants

Primary outcome timeframe

From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

Results posted on

2023-03-02

Participant Flow

The first patient registration was on 25 August 2015 and the first study treatment administration was on 25 August 2015. The last patient registration was on 30 November 2018 and the last study treatment administration was on 29 November 2019. The date of last follow-up (cutoff-date) was 18 September 2020.

Participant milestones

Participant milestones
Measure
Biliary Tract Carcinoma Cohort
Patients with Pathologically proven diagnosis of biliary tract carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Carcinoma of Unknown Primary Site Cohort
Patients with pathologically proven diagnosis of carcinoma of unknown primary site Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Endometrial Carcinoma Cohort
Patients with pathologically proven diagnosis of endometrial carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Ewing's Family of Tumors Cohort
Patients with pathologically proven diagnosis of Ewing's Family of Tumors Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Germ Cell Tumors Cohort
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Head and Neck Carcinoma Cohort
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Neuroendocrine Tumors Cohort
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Small Cell Lung Cancer Cohort
Patients with pathologically proven diagnosis of small cell lung cancer Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Overall Study
STARTED
19
19
76
29
24
15
21
32
110
Overall Study
Treated
19
19
73
28
23
15
21
32
105
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
19
19
76
29
24
15
21
32
110

Reasons for withdrawal

Reasons for withdrawal
Measure
Biliary Tract Carcinoma Cohort
Patients with Pathologically proven diagnosis of biliary tract carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Carcinoma of Unknown Primary Site Cohort
Patients with pathologically proven diagnosis of carcinoma of unknown primary site Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Endometrial Carcinoma Cohort
Patients with pathologically proven diagnosis of endometrial carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Ewing's Family of Tumors Cohort
Patients with pathologically proven diagnosis of Ewing's Family of Tumors Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Germ Cell Tumors Cohort
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Head and Neck Carcinoma Cohort
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Neuroendocrine Tumors Cohort
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification. Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Small Cell Lung Cancer Cohort
Patients with pathologically proven diagnosis of small cell lung cancer Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\^2. Dose was capped at body surface area (BSA) of 2.0 m\^2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Overall Study
Progressive disease
17
16
59
23
16
12
19
27
0
Overall Study
Death
0
0
5
1
0
0
0
0
95
Overall Study
Physician Decision
0
1
2
1
2
0
0
1
0
Overall Study
Non treatment-related adverse event
2
0
1
0
0
1
0
1
0
Overall Study
Treatment-related adverse events
0
1
1
0
2
0
0
2
0
Overall Study
Patient moves to compassionate use
0
0
0
0
0
0
2
0
0
Overall Study
Withdrawal by Subject
0
1
5
2
3
2
0
1
2
Overall Study
Multiple delay/holds on treatment
0
0
0
1
0
0
0
0
0
Overall Study
Never treated
0
0
3
1
1
0
0
0
5
Overall Study
Lost to Follow-up
0
0
0
0
0
0
0
0
2
Overall Study
Study termination
0
0
0
0
0
0
0
0
6

Baseline Characteristics

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Biliary Tract Carcinoma Cohort
n=19 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=73 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=15 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=32 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Total
n=335 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
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=5 Participants
10 Participants
n=7 Participants
37 Participants
n=5 Participants
27 Participants
n=4 Participants
20 Participants
n=21 Participants
9 Participants
n=10 Participants
19 Participants
n=115 Participants
19 Participants
n=6 Participants
68 Participants
n=6 Participants
222 Participants
n=64 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
9 Participants
n=7 Participants
36 Participants
n=5 Participants
1 Participants
n=4 Participants
3 Participants
n=21 Participants
6 Participants
n=10 Participants
2 Participants
n=115 Participants
13 Participants
n=6 Participants
37 Participants
n=6 Participants
113 Participants
n=64 Participants
Age, Continuous
61 years
n=5 Participants
61 years
n=7 Participants
64 years
n=5 Participants
33 years
n=4 Participants
36 years
n=21 Participants
62 years
n=10 Participants
45 years
n=115 Participants
63 years
n=6 Participants
60 years
n=6 Participants
60 years
n=64 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
11 Participants
n=7 Participants
73 Participants
n=5 Participants
12 Participants
n=4 Participants
7 Participants
n=21 Participants
1 Participants
n=10 Participants
21 Participants
n=115 Participants
12 Participants
n=6 Participants
42 Participants
n=6 Participants
189 Participants
n=64 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
8 Participants
n=7 Participants
0 Participants
n=5 Participants
16 Participants
n=4 Participants
16 Participants
n=21 Participants
14 Participants
n=10 Participants
0 Participants
n=115 Participants
20 Participants
n=6 Participants
63 Participants
n=6 Participants
146 Participants
n=64 Participants
Race/Ethnicity, Customized
White
13 Participants
n=5 Participants
15 Participants
n=7 Participants
45 Participants
n=5 Participants
21 Participants
n=4 Participants
15 Participants
n=21 Participants
12 Participants
n=10 Participants
18 Participants
n=115 Participants
24 Participants
n=6 Participants
79 Participants
n=6 Participants
242 Participants
n=64 Participants
Race/Ethnicity, Customized
Black of African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
7 Participants
n=64 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
6 Participants
n=64 Participants
Race/Ethnicity, Customized
American Indian or Alaska native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=64 Participants
Race/Ethnicity, Customized
Not race available
6 Participants
n=5 Participants
4 Participants
n=7 Participants
22 Participants
n=5 Participants
4 Participants
n=4 Participants
7 Participants
n=21 Participants
2 Participants
n=10 Participants
3 Participants
n=115 Participants
7 Participants
n=6 Participants
24 Participants
n=6 Participants
79 Participants
n=64 Participants
Region of Enrollment
Sweden
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
1 Participants
n=64 Participants
Region of Enrollment
Belgium
2 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
13 Participants
n=64 Participants
Region of Enrollment
United States
3 Participants
n=5 Participants
6 Participants
n=7 Participants
17 Participants
n=5 Participants
16 Participants
n=4 Participants
12 Participants
n=21 Participants
4 Participants
n=10 Participants
2 Participants
n=115 Participants
6 Participants
n=6 Participants
11 Participants
n=6 Participants
77 Participants
n=64 Participants
Region of Enrollment
Italy
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
2 Participants
n=6 Participants
6 Participants
n=64 Participants
Region of Enrollment
United Kingdom
0 Participants
n=5 Participants
1 Participants
n=7 Participants
9 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
3 Participants
n=6 Participants
13 Participants
n=64 Participants
Region of Enrollment
France
4 Participants
n=5 Participants
2 Participants
n=7 Participants
17 Participants
n=5 Participants
3 Participants
n=4 Participants
6 Participants
n=21 Participants
2 Participants
n=10 Participants
3 Participants
n=115 Participants
5 Participants
n=6 Participants
20 Participants
n=6 Participants
62 Participants
n=64 Participants
Region of Enrollment
Switzerland
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=6 Participants
7 Participants
n=6 Participants
10 Participants
n=64 Participants
Region of Enrollment
Germany
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
2 Participants
n=64 Participants
Region of Enrollment
Spain
10 Participants
n=5 Participants
8 Participants
n=7 Participants
23 Participants
n=5 Participants
5 Participants
n=4 Participants
4 Participants
n=21 Participants
9 Participants
n=10 Participants
15 Participants
n=115 Participants
18 Participants
n=6 Participants
59 Participants
n=6 Participants
151 Participants
n=64 Participants
Eastern Cooperative Oncology Group performance status
0
5 Participants
n=5 Participants
8 Participants
n=7 Participants
32 Participants
n=5 Participants
11 Participants
n=4 Participants
2 Participants
n=21 Participants
5 Participants
n=10 Participants
18 Participants
n=115 Participants
8 Participants
n=6 Participants
38 Participants
n=6 Participants
127 Participants
n=64 Participants
Eastern Cooperative Oncology Group performance status
1
14 Participants
n=5 Participants
10 Participants
n=7 Participants
35 Participants
n=5 Participants
16 Participants
n=4 Participants
19 Participants
n=21 Participants
10 Participants
n=10 Participants
2 Participants
n=115 Participants
23 Participants
n=6 Participants
59 Participants
n=6 Participants
188 Participants
n=64 Participants
Eastern Cooperative Oncology Group performance status
2
0 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
1 Participants
n=6 Participants
8 Participants
n=6 Participants
20 Participants
n=64 Participants
Weight
72.2 kg
n=5 Participants
65.0 kg
n=7 Participants
70.0 kg
n=5 Participants
77.0 kg
n=4 Participants
78.5 kg
n=21 Participants
73.0 kg
n=10 Participants
65.5 kg
n=115 Participants
64.0 kg
n=6 Participants
71.0 kg
n=6 Participants
71.0 kg
n=64 Participants
Height
168 cm
n=5 Participants
164.5 cm
n=7 Participants
161 cm
n=5 Participants
173 cm
n=4 Participants
177 cm
n=21 Participants
170 cm
n=10 Participants
163.0 cm
n=115 Participants
169 cm
n=6 Participants
167 cm
n=6 Participants
165 cm
n=64 Participants
Body surface area
1.9 m^2
n=5 Participants
1.8 m^2
n=7 Participants
1.8 m^2
n=5 Participants
1.9 m^2
n=4 Participants
2.0 m^2
n=21 Participants
1.8 m^2
n=10 Participants
1.7 m^2
n=115 Participants
1.7 m^2
n=6 Participants
1.8 m^2
n=6 Participants
1.8 m^2
n=64 Participants
Albumin
3.7 g/dL
n=5 Participants
3.7 g/dL
n=7 Participants
4.1 g/dL
n=5 Participants
4.2 g/dL
n=4 Participants
4.1 g/dL
n=21 Participants
3.8 g/dL
n=10 Participants
4.1 g/dL
n=115 Participants
4.0 g/dL
n=6 Participants
4.1 g/dL
n=6 Participants
4.0 g/dL
n=64 Participants
Albumin
<3.5 g/dL
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
2 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=10 Participants
1 Participants
n=115 Participants
9 Participants
n=6 Participants
13 Participants
n=6 Participants
50 Participants
n=64 Participants
Albumin
≥3.5 g/dL
14 Participants
n=5 Participants
15 Participants
n=7 Participants
64 Participants
n=5 Participants
26 Participants
n=4 Participants
19 Participants
n=21 Participants
12 Participants
n=10 Participants
20 Participants
n=115 Participants
23 Participants
n=6 Participants
92 Participants
n=6 Participants
285 Participants
n=64 Participants
Stage at diagnosis
Early
0 Participants
n=5 Participants
0 Participants
n=7 Participants
23 Participants
n=5 Participants
14 Participants
n=4 Participants
8 Participants
n=21 Participants
4 Participants
n=10 Participants
10 Participants
n=115 Participants
5 Participants
n=6 Participants
3 Participants
n=6 Participants
67 Participants
n=64 Participants
Stage at diagnosis
Locally advanced
4 Participants
n=5 Participants
0 Participants
n=7 Participants
27 Participants
n=5 Participants
5 Participants
n=4 Participants
1 Participants
n=21 Participants
7 Participants
n=10 Participants
6 Participants
n=115 Participants
8 Participants
n=6 Participants
29 Participants
n=6 Participants
87 Participants
n=64 Participants
Stage at diagnosis
Metastatic
15 Participants
n=5 Participants
19 Participants
n=7 Participants
23 Participants
n=5 Participants
9 Participants
n=4 Participants
14 Participants
n=21 Participants
4 Participants
n=10 Participants
5 Participants
n=115 Participants
19 Participants
n=6 Participants
73 Participants
n=6 Participants
181 Participants
n=64 Participants
Number of sites at baseline
3 sites at baseline
n=5 Participants
2 sites at baseline
n=7 Participants
2 sites at baseline
n=5 Participants
2 sites at baseline
n=4 Participants
3 sites at baseline
n=21 Participants
2 sites at baseline
n=10 Participants
2 sites at baseline
n=115 Participants
3 sites at baseline
n=6 Participants
3 sites at baseline
n=6 Participants
3 sites at baseline
n=64 Participants
Sites at baseline
<3 sites
6 Participants
n=5 Participants
12 Participants
n=7 Participants
40 Participants
n=5 Participants
18 Participants
n=4 Participants
7 Participants
n=21 Participants
10 Participants
n=10 Participants
12 Participants
n=115 Participants
13 Participants
n=6 Participants
26 Participants
n=6 Participants
144 Participants
n=64 Participants
Sites at baseline
≥3 sites
13 Participants
n=5 Participants
7 Participants
n=7 Participants
33 Participants
n=5 Participants
10 Participants
n=4 Participants
16 Participants
n=21 Participants
5 Participants
n=10 Participants
9 Participants
n=115 Participants
19 Participants
n=6 Participants
79 Participants
n=6 Participants
191 Participants
n=64 Participants
Time from diagnosis to registration
8.4 months
n=5 Participants
10.8 months
n=7 Participants
18.4 months
n=5 Participants
28.6 months
n=4 Participants
48.2 months
n=21 Participants
19.5 months
n=10 Participants
50.1 months
n=115 Participants
13.3 months
n=6 Participants
8.2 months
n=6 Participants
13.7 months
n=64 Participants
Time from advanced disease to registration
10.6 month
n=5 Participants
NA month
n=7 Participants
17.5 month
n=5 Participants
20.4 month
n=4 Participants
33.5 month
n=21 Participants
18.4 month
n=10 Participants
31.9 month
n=115 Participants
17.2 month
n=6 Participants
9.1 month
n=6 Participants
15.0 month
n=64 Participants
Prior surgery
2 Participants
n=5 Participants
2 Participants
n=7 Participants
62 Participants
n=5 Participants
20 Participants
n=4 Participants
21 Participants
n=21 Participants
9 Participants
n=10 Participants
19 Participants
n=115 Participants
11 Participants
n=6 Participants
2 Participants
n=6 Participants
148 Participants
n=64 Participants
Prior radiotherapy
2 Participants
n=5 Participants
8 Participants
n=7 Participants
39 Participants
n=5 Participants
20 Participants
n=4 Participants
7 Participants
n=21 Participants
11 Participants
n=10 Participants
20 Participants
n=115 Participants
7 Participants
n=6 Participants
76 Participants
n=6 Participants
190 Participants
n=64 Participants
Systemic lines
1 line
13 Participants
n=5 Participants
12 Participants
n=7 Participants
54 Participants
n=5 Participants
5 Participants
n=4 Participants
0 Participants
n=21 Participants
5 Participants
n=10 Participants
0 Participants
n=115 Participants
14 Participants
n=6 Participants
98 Participants
n=6 Participants
201 Participants
n=64 Participants
Systemic lines
2 lines
6 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
15 Participants
n=4 Participants
4 Participants
n=21 Participants
8 Participants
n=10 Participants
7 Participants
n=115 Participants
13 Participants
n=6 Participants
7 Participants
n=6 Participants
82 Participants
n=64 Participants
Systemic lines
3 lines
0 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
5 Participants
n=4 Participants
8 Participants
n=21 Participants
2 Participants
n=10 Participants
7 Participants
n=115 Participants
4 Participants
n=6 Participants
0 Participants
n=6 Participants
29 Participants
n=64 Participants
Systemic lines
4 or more lines
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
11 Participants
n=21 Participants
0 Participants
n=10 Participants
7 Participants
n=115 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
23 Participants
n=64 Participants
Advanced chemotherapy lines
0 lines
19 Participants
n=5 Participants
0 Participants
n=7 Participants
15 Participants
n=5 Participants
5 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=6 Participants
105 Participants
n=6 Participants
145 Participants
n=64 Participants
Advanced chemotherapy lines
1 line
0 Participants
n=5 Participants
12 Participants
n=7 Participants
47 Participants
n=5 Participants
7 Participants
n=4 Participants
1 Participants
n=21 Participants
5 Participants
n=10 Participants
5 Participants
n=115 Participants
17 Participants
n=6 Participants
0 Participants
n=6 Participants
94 Participants
n=64 Participants
Advanced chemotherapy lines
2 lines
0 Participants
n=5 Participants
7 Participants
n=7 Participants
8 Participants
n=5 Participants
13 Participants
n=4 Participants
4 Participants
n=21 Participants
9 Participants
n=10 Participants
7 Participants
n=115 Participants
10 Participants
n=6 Participants
0 Participants
n=6 Participants
58 Participants
n=64 Participants
Advanced chemotherapy lines
3 lines
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
8 Participants
n=21 Participants
1 Participants
n=10 Participants
6 Participants
n=115 Participants
4 Participants
n=6 Participants
0 Participants
n=6 Participants
24 Participants
n=64 Participants
Advanced chemotherapy lines
4 or more lines
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
10 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=6 Participants
0 Participants
n=6 Participants
14 Participants
n=64 Participants
Best response to last therapy
Complete response
0 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=6 Participants
9 Participants
n=6 Participants
20 Participants
n=64 Participants
Best response to last therapy
Partial reponse
4 Participants
n=5 Participants
4 Participants
n=7 Participants
20 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
5 Participants
n=10 Participants
2 Participants
n=115 Participants
5 Participants
n=6 Participants
70 Participants
n=6 Participants
112 Participants
n=64 Participants
Best response to last therapy
Stable disease
7 Participants
n=5 Participants
5 Participants
n=7 Participants
13 Participants
n=5 Participants
0 Participants
n=4 Participants
5 Participants
n=21 Participants
2 Participants
n=10 Participants
6 Participants
n=115 Participants
14 Participants
n=6 Participants
19 Participants
n=6 Participants
71 Participants
n=64 Participants
Best response to last therapy
Progression disease
8 Participants
n=5 Participants
4 Participants
n=7 Participants
15 Participants
n=5 Participants
0 Participants
n=4 Participants
15 Participants
n=21 Participants
7 Participants
n=10 Participants
7 Participants
n=115 Participants
11 Participants
n=6 Participants
4 Participants
n=6 Participants
71 Participants
n=64 Participants
Best response to last therapy
Unknown
0 Participants
n=5 Participants
3 Participants
n=7 Participants
18 Participants
n=5 Participants
28 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
5 Participants
n=115 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
61 Participants
n=64 Participants
Time to progression to last prior therapy
5.2 months
n=5 Participants
3.9 months
n=7 Participants
8.0 months
n=5 Participants
8.7 months
n=4 Participants
2.7 months
n=21 Participants
4.6 months
n=10 Participants
5.0 months
n=115 Participants
3.6 months
n=6 Participants
6.5 months
n=6 Participants
6.4 months
n=64 Participants
Time from last progression disease before study entry
3.0 weeks
n=5 Participants
2.6 weeks
n=7 Participants
2.9 weeks
n=5 Participants
2.1 weeks
n=4 Participants
1.4 weeks
n=21 Participants
2.4 weeks
n=10 Participants
1.6 weeks
n=115 Participants
2.6 weeks
n=6 Participants
1.6 weeks
n=6 Participants
2.1 weeks
n=64 Participants

PRIMARY outcome

Timeframe: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

Population: Treated patients and with disease measurement

Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Overall Response Rate (ORR)
5.6 percentage of participants
Interval 0.1 to 27.3
0.0 percentage of participants
Interval 0.0 to 17.6
11.3 percentage of participants
Interval 5.0 to 21.0
14.3 percentage of participants
Interval 4.0 to 32.7
4.3 percentage of participants
Interval 0.1 to 21.9
0.0 percentage of participants
Interval 0.0 to 24.7
28.6 percentage of participants
Interval 11.3 to 55.2
6.5 percentage of participants
Interval 0.8 to 21.4
36.2 percentage of participants
Interval 27.0 to 46.1

PRIMARY outcome

Timeframe: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

Population: Treated patients with disease measurement

When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Response by Investigator Assessment
Complete Response
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Response by Investigator Assessment
Partial Response
1 Participants
0 Participants
6 Participants
4 Participants
1 Participants
0 Participants
6 Participants
2 Participants
38 Participants
Response by Investigator Assessment
Stable Disease
5 Participants
11 Participants
29 Participants
12 Participants
8 Participants
3 Participants
10 Participants
9 Participants
34 Participants
Response by Investigator Assessment
Progressive disease
11 Participants
7 Participants
30 Participants
9 Participants
12 Participants
8 Participants
5 Participants
18 Participants
28 Participants
Response by Investigator Assessment
Inevaluable for response
1 Participants
1 Participants
4 Participants
3 Participants
2 Participants
2 Participants
0 Participants
2 Participants
5 Participants

SECONDARY outcome

Timeframe: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

Population: Patients with response to treatment

Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=1 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=8 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=4 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=1 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=6 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=2 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=38 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Duration of Response
3.4 months
Only 1 patient
—
9.2 months
Interval 3.4 to 18.0
4.2 months
Interval 2.9 to 5.5
10.6 months
Only 1 patient
—
8.6 months
Interval 2.9 to
Not reached
4.7 months
Interval 4.0 to 5.4
5.3 months
Interval 4.1 to 6.2

SECONDARY outcome

Timeframe: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

Population: Treated patients with disease measurement

Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Clinical Benefit
11.1 percentage of participants
Interval 1.4 to 34.7
36.8 percentage of participants
Interval 16.3 to 61.6
35.2 percentage of participants
Interval 24.2 to 47.5
39.3 percentage of participants
Interval 21.5 to 59.4
26.1 percentage of participants
Interval 10.2 to 48.4
15.4 percentage of participants
Interval 1.9 to 45.4
57.1 percentage of participants
Interval 34.0 to 78.2
29.0 percentage of participants
Interval 14.2 to 48.0
45.7 percentage of participants
Interval 36.0 to 55.7

SECONDARY outcome

Timeframe: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6

Population: Treated patients with disease measurement

Disease Control Rate was defined as Overall Response Rate or Stable Disease

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Disease Control Rate
33.3 percentage of paticipants
Interval 13.3 to 59.0
57.9 percentage of paticipants
Interval 33.5 to 79.7
52.1 percentage of paticipants
Interval 39.9 to 64.1
57.1 percentage of paticipants
Interval 37.2 to 75.5
39.1 percentage of paticipants
Interval 19.7 to 61.5
23.1 percentage of paticipants
Interval 5.0 to 53.8
76.2 percentage of paticipants
Interval 52.8 to 91.8
35.5 percentage of paticipants
Interval 19.2 to 54.6
68.6 percentage of paticipants
Interval 58.8 to 77.3

SECONDARY outcome

Timeframe: From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years

Population: Treated patients with disease measurement

Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Progression Free Survival (PFS)
1.3 months
Interval 1.1 to 2.5
2.7 months
Interval 1.3 to 4.4
2.6 months
Interval 1.4 to 4.0
2.7 months
Interval 1.4 to 4.3
1.5 months
Interval 0.9 to 8.9
1.3 months
Interval 1.2 to 2.1
4.1 months
Interval 2.3 to 6.5
1.4 months
Interval 1.2 to 3.0
3.7 months
Interval 2.6 to 4.3

SECONDARY outcome

Timeframe: At 4 months

Population: Treated patients with disease measurement

Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Progression-free Survival at 4 Months
13.7 percentage of participants
Interval 0.0 to 31.1
38.9 percentage of participants
Interval 16.4 to 61.4
39.7 percentage of participants
Interval 28.2 to 51.3
46.2 percentage of participants
Interval 27.0 to 65.3
30.7 percentage of participants
Interval 11.0 to 50.4
15.4 percentage of participants
Interval 0.0 to 35.0
57.1 percentage of participants
Interval 36.0 to 78.3
30.0 percentage of participants
Interval 13.6 to 46.4
46.5 percentage of participants
Interval 36.8 to 56.3

SECONDARY outcome

Timeframe: At 6 months

Population: Treated patients with disease measurement

Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Progression-free Survival at 6 Months
13.7 percentage of participants
Interval 0.0 to 31.1
22.2 percentage of participants
Interval 3.0 to 41.4
29.0 percentage of participants
Interval 18.2 to 39.8
23.1 percentage of participants
Interval 5.9 to 40.3
30.7 percentage of participants
Interval 11.0 to 50.4
7.7 percentage of participants
Interval 0.0 to 22.2
33.3 percentage of participants
Interval 13.2 to 53.5
16.7 percentage of participants
Interval 3.3 to 30.0
33.4 percentage of participants
Interval 24.1 to 42.6

SECONDARY outcome

Timeframe: From the date of first infusion to the date of death or last contact, up to an average of 5 years

Population: Treated patients with disease measurement

Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort.

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Overall Survival (OS)
7.3 months
Interval 2.7 to 8.9
7.7 months
Interval 3.8 to 18.8
9.3 months
Interval 6.1 to 12.8
12.0 months
Interval 8.5 to 18.5
9.2 months
Interval 2.7 to 17.4
5.7 months
Interval 2.1 to 12.1
16.1 months
Interval 8.7 to
Not reached
7.4 months
Interval 3.4 to 16.2
8.1 months
Interval 6.5 to 10.9

SECONDARY outcome

Timeframe: At 6 months

Population: Treated patients with disease measurement

Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Overall Survival at 6 Months
58.2 percentage of participants
Interval 34.5 to 82.0
55.6 percentage of participants
Interval 32.6 to 78.5
62.8 percentage of participants
Interval 51.2 to 74.4
88.2 percentage of participants
Interval 75.7 to 100.0
55.0 percentage of participants
Interval 32.8 to 77.1
38.5 percentage of participants
Interval 12.0 to 64.9
79.2 percentage of participants
Interval 61.0 to 97.4
52.1 percentage of participants
Interval 33.9 to 70.3
68.6 percentage of participants
Interval 59.5 to 77.6

SECONDARY outcome

Timeframe: At 12 months

Population: Treated patients with disease measurement

Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months

Outcome measures

Outcome measures
Measure
Biliary Tract Carcinoma Cohort
n=18 Participants
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
n=19 Participants
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
n=71 Participants
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
n=28 Participants
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
n=23 Participants
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
n=13 Participants
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
n=21 Participants
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
n=31 Participants
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
n=105 Participants
Patients with pathologically proven diagnosis of small cell lung cancer
Overall Survival at 12 Months
21.8 percentage of participants
Interval 0.4 to 43.3
36.5 percentage of participants
Interval 13.1 to 59.8
45.8 percentage of participants
Interval 33.8 to 75.9
48.5 percentage of participants
Interval 27.8 to 69.2
34.4 percentage of participants
Interval 11.3 to 57.4
30.8 percentage of participants
Interval 5.7 to 55.9
58.1 percentage of participants
Interval 35.9 to 80.2
38.2 percentage of participants
Interval 20.5 to 55.9
34.8 percentage of participants
Interval 25.5 to 44.1

Adverse Events

Lurbinectedin (PM01183)

Serious events: 136 serious events
Other events: 330 other events
Deaths: 261 deaths

Serious adverse events

Serious adverse events
Measure
Lurbinectedin (PM01183)
n=335 participants at risk
Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
General disorders
General physical health deterioration
4.5%
15/335 • Number of events 21 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Anaemia
3.0%
10/335 • Number of events 18 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Febrile neutropenia
6.0%
20/335 • Number of events 21 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Leukopenia
0.60%
2/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Lymphopenia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Neutropenia
4.5%
15/335 • Number of events 22 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Thrombocytopenia
3.6%
12/335 • Number of events 36 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Cardiac disorders
Tachycardia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Endocrine disorders
Cushing's syndrome
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Abdominal pain
3.3%
11/335 • Number of events 12 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Colitis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Diarrhoea
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Dysphagia
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Intestinal obstruction
1.2%
4/335 • Number of events 5 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Intra-abdominal haemorrhage
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Nausea
1.2%
4/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Small intestinal obstruction
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.60%
2/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Vomiting
2.1%
7/335 • Number of events 9 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Asthenia
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Gait disturbance
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Non-cardiac chest pain
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Oedema
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Oedema peripheral
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Pain
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Pyrexia
1.8%
6/335 • Number of events 8 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Hepatobiliary disorders
Cholangitis
0.90%
3/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Hepatobiliary disorders
Hyperbilirubinaemia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Hepatobiliary disorders
Jaundice cholestatic
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Bacteraemia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Biliary tract infection
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Bronchitis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Device related infection
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Escherichia urinary tract infection
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Lung infection
0.90%
3/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Peritonitis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Pneumonia
2.4%
8/335 • Number of events 10 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Pseudomonal bacteraemia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Respiratory tract infection
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Sepsis
0.90%
3/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Septic shock
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Skin infection
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Upper respiratory tract infection
1.2%
4/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Infections and infestations
Urinary tract infection
1.2%
4/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Injury, poisoning and procedural complications
Compression fracture
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Injury, poisoning and procedural complications
Spinal fracture
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Injury, poisoning and procedural complications
Vascular access complication
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Alanine aminotransferase increased
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Aspartate aminotransferase increased
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Blood calcium decreased
0.30%
1/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Blood creatinine increased
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Blood phosphorus decreased
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Neutrophil count decreased
0.60%
2/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Platelet count decreased
0.60%
2/335 • Number of events 5 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Decreased appetite
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Dehydration
1.2%
4/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Hypoalbuminaemia
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Hyponatraemia
2.1%
7/335 • Number of events 11 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Back pain
1.2%
4/335 • Number of events 5 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Bone pain
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Muscular weakness
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Pain in extremity
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.60%
2/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Aphasia
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Cerebrovascular accident
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Cognitive disorder
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Dizziness
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Facial paralysis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Headache
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Hemiplegia
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Neuralgia
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Seizure
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Spinal cord compression
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Subacute combined cord degeneration
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Syncope
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Product Issues
Device malfunction
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Psychiatric disorders
Confusional state
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Psychiatric disorders
Mental status changes
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Renal and urinary disorders
Haematuria
1.2%
4/335 • Number of events 5 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Renal and urinary disorders
Hydronephrosis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Renal and urinary disorders
Renal failure
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Aspiration
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.30%
1/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.4%
8/335 • Number of events 13 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.90%
3/335 • Number of events 3 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.2%
4/335 • Number of events 4 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Surgical and medical procedures
Cementoplasty
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Vascular disorders
Deep vein thrombosis
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Vascular disorders
Embolism
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Vascular disorders
Superior vena cava occlusion
0.30%
1/335 • Number of events 1 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Vascular disorders
Superior vena cava syndrome
0.60%
2/335 • Number of events 2 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)

Other adverse events

Other adverse events
Measure
Lurbinectedin (PM01183)
n=335 participants at risk
Lurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m2. Dose was capped at body surface area (BSA) of 2.0 m2 (i.e., dose did not exceed 6.4 mg). Patients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).
Blood and lymphatic system disorders
Anaemia
17.6%
59/335 • Number of events 100 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Blood and lymphatic system disorders
Neutropenia
26.6%
89/335 • Number of events 174 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Abdominal pain
16.1%
54/335 • Number of events 83 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Abdominal pain upper
5.7%
19/335 • Number of events 21 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Constipation
34.6%
116/335 • Number of events 189 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Diarrhoea
18.5%
62/335 • Number of events 104 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Nausea
49.9%
167/335 • Number of events 276 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Gastrointestinal disorders
Vomiting
22.7%
76/335 • Number of events 126 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Asthenia
38.5%
129/335 • Number of events 335 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Chest pain
6.9%
23/335 • Number of events 28 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Fatigue
36.4%
122/335 • Number of events 242 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Mucosal inflammation
5.7%
19/335 • Number of events 23 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Oedema peripheral
9.0%
30/335 • Number of events 35 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
General disorders
Pyrexia
14.3%
48/335 • Number of events 56 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Investigations
Weight decreased
7.5%
25/335 • Number of events 33 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Decreased appetite
30.4%
102/335 • Number of events 144 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Metabolism and nutrition disorders
Hypoalbuminaemia
5.4%
18/335 • Number of events 31 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Arthralgia
6.9%
23/335 • Number of events 28 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Back pain
15.2%
51/335 • Number of events 71 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
6.0%
20/335 • Number of events 25 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Musculoskeletal and connective tissue disorders
Pain in extremity
6.9%
23/335 • Number of events 32 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
8.4%
28/335 • Number of events 34 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Headache
7.5%
25/335 • Number of events 28 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Nervous system disorders
Neuropathy peripheral
5.7%
19/335 • Number of events 27 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Psychiatric disorders
Insomnia
10.1%
34/335 • Number of events 37 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Cough
17.3%
58/335 • Number of events 71 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
23.0%
77/335 • Number of events 99 • From the date of first infusion to the date of death or last contact, up to an average of 5 years
Safety in the entire trial population is a secondary objective defined in the protocol as all patients were exposed to the same unique dose of lurbinectedin. Consequently, adverse events are reported in a combined mode for all groups (cohorts) to provide a clear picture of the drug safety in the whole population. Out of the 345 patients enrolled there were 10 patients who did not receive lurbinectedin treatment so patients at risk is 335 (345-10)

Additional Information

Clinical Development, Department of PharmaMar´s Oncology., Business Unit.

Pharma Mar S.A.

Phone: 0034 91846 60 00

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