NCT02454972 · OUTCOME

Disease Control Rate

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: NUMBER
Unit: percentage of paticipants
Interval / dispersion: 95% Confidence Interval
Time frame: 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

What was measured

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

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 percentage of paticipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Biliary Tract Carcinoma Cohort	33.3	Not reported	13.3	59.0	Not reported
Carcinoma of Unknown Primary Site Cohort	57.9	Not reported	33.5	79.7	Not reported
Endometrial Carcinoma Cohort	52.1	Not reported	39.9	64.1	Not reported
Ewing's Family of Tumors Cohort	57.1	Not reported	37.2	75.5	Not reported
Germ Cell Tumors Cohort	39.1	Not reported	19.7	61.5	Not reported
Head and Neck Carcinoma Cohort	23.1	Not reported	5.0	53.8	Not reported
BRCA1/2-associated Metastatic Breast Carcinoma Cohort	76.2	Not reported	52.8	91.8	Not reported
Neuroendocrine Tumors Cohort	35.5	Not reported	19.2	54.6	Not reported
Small Cell Lung Cancer Cohort	68.6	Not reported	58.8	77.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
13.3
upper Limit
59.0
value
33.3
group Id
OG001
lower Limit
33.5
upper Limit
79.7
value
57.9
group Id
OG002
lower Limit
39.9
upper Limit
64.1
value
52.1
group Id
OG003
lower Limit
37.2
upper Limit
75.5
value
57.1
group Id
OG004
lower Limit
19.7
upper Limit
61.5
value
39.1
group Id
OG005
lower Limit
5.0
upper Limit
53.8
value
23.1
group Id
OG006
lower Limit
52.8
upper Limit
91.8
value
76.2
group Id
OG007
lower Limit
19.2
upper Limit
54.6
value
35.5
group Id
OG008
lower Limit
58.8
upper Limit
77.3
value
68.6

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

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

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

NUMBER

population Description

Treated patients with disease measurement

reporting Status

POSTED

time Frame

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

title

Disease Control Rate

type

SECONDARY

unit Of Measure

percentage of paticipants

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

Preserved source evidence · Not medical advice