NCT02454972 · OUTCOME

Overall Survival (OS)

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors · Source last updated 2023-03-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From the date of first infusion to the date of death or last contact, up to an average of 5 years

What was measured

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.

Analysis population: Treated patients with disease measurement

Groups in this outcome

Biliary Tract Carcinoma Cohort

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

Patients with pathologically proven diagnosis of endometrial carcinoma

Ewing's Family of Tumors Cohort

Patients with pathologically proven diagnosis of Ewing's Family of Tumors

Germ Cell Tumors Cohort

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

Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma

Neuroendocrine Tumors Cohort

Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.

Small Cell Lung Cancer Cohort

Patients with pathologically proven diagnosis of small cell lung cancer

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Biliary Tract Carcinoma Cohort	18
Carcinoma of Unknown Primary Site Cohort	19
Endometrial Carcinoma Cohort	71
Ewing's Family of Tumors Cohort	28
Germ Cell Tumors Cohort	23
Head and Neck Carcinoma Cohort	13
BRCA1/2-associated Metastatic Breast Carcinoma Cohort	21
Neuroendocrine Tumors Cohort	31
Small Cell Lung Cancer Cohort	105

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Biliary Tract Carcinoma Cohort	7.3	Not reported	2.7	8.9	Not reported
Carcinoma of Unknown Primary Site Cohort	7.7	Not reported	3.8	18.8	Not reported
Endometrial Carcinoma Cohort	9.3	Not reported	6.1	12.8	Not reported
Ewing's Family of Tumors Cohort	12.0	Not reported	8.5	18.5	Not reported
Germ Cell Tumors Cohort	9.2	Not reported	2.7	17.4	Not reported
Head and Neck Carcinoma Cohort	5.7	Not reported	2.1	12.1	Not reported
BRCA1/2-associated Metastatic Breast Carcinoma Cohort	16.1	Not reported	8.7	NA	Not reached
Neuroendocrine Tumors Cohort	7.4	Not reported	3.4	16.2	Not reported
Small Cell Lung Cancer Cohort	8.1	Not reported	6.5	10.9	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
2.7
upper Limit
8.9
value
7.3
group Id
OG001
lower Limit
3.8
upper Limit
18.8
value
7.7
group Id
OG002
lower Limit
6.1
upper Limit
12.8
value
9.3
group Id
OG003
lower Limit
8.5
upper Limit
18.5
value
12.0
group Id
OG004
lower Limit
2.7
upper Limit
17.4
value
9.2
group Id
OG005
lower Limit
2.1
upper Limit
12.1
value
5.7
comment
Not reached
group Id
OG006
lower Limit
8.7
upper Limit
NA
value
16.1
group Id
OG007
lower Limit
3.4
upper Limit
16.2
value
7.4
group Id
OG008
lower Limit
6.5
upper Limit
10.9
value
8.1

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
19
group Id
OG002
value
71
group Id
OG003
value
28
group Id
OG004
value
23
group Id
OG005
value
13
group Id
OG006
value
21
group Id
OG007
value
31
group Id
OG008
value
105
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Patients with Pathologically proven diagnosis of biliary tract carcinoma
id
OG000
title
Biliary Tract Carcinoma Cohort
description
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
id
OG001
title
Carcinoma of Unknown Primary Site Cohort
description
Patients with pathologically proven diagnosis of endometrial carcinoma
id
OG002
title
Endometrial Carcinoma Cohort
description
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
id
OG003
title
Ewing's Family of Tumors Cohort
description
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
id
OG004
title
Germ Cell Tumors Cohort
description
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
id
OG005
title
Head and Neck Carcinoma Cohort
description
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
id
OG006
title
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
description
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
id
OG007
title
Neuroendocrine Tumors Cohort
description
Patients with pathologically proven diagnosis of small cell lung cancer
id
OG008
title
Small Cell Lung Cancer Cohort

param Type

MEDIAN

population Description

Treated patients with disease measurement

reporting Status

POSTED

time Frame

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

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice