NCT01907100 · REGISTRY CONDITION SEARCH

Nintedanib (BIBF 1120) in Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2, PHASE3
Status at capture: TERMINATED
Registry last update: 2019-03-18

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Objective Response According to Modified RECIST- Investigator Assessment

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outcome · POSTED

Disease Control According to Modified RECIST- Investigator Assessment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion criteria: * Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients) * Life expectancy of at least 3 months in the opinion of the investigator * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria Exclusion criteria: * Previous systemic chemotherapy for MPM * Prior treatment with nintedanib or any other prior line of therapy * Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM * Patients with symptomatic neuropathy * Radiotherapy (except extremities) within 3 months prior to baseline imaging * Active brain metastases (e.g. stable for \< 4 weeks) * Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM * Significant cardiovascular diseases * Inadequate hematologic, renal, or hepatic function
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Placebo controlled arm
intervention Names
Drug: Pemetrexed
Drug: Cisplatin
Drug: Placebo
label
Placebo + pemetrexed/cisplatin
type
PLACEBO_COMPARATOR
description
Experimental arm
intervention Names
Drug: Nintedanib
Drug: Cisplatin
Drug: Pemetrexed
label
Nintedanib 200mg + pemetrexed/cisplatin
type
EXPERIMENTAL

interventions

arm Group Labels
Nintedanib 200mg + pemetrexed/cisplatin
description
triple kinase inhibitor; 200mg starting dose
name
Nintedanib
type
DRUG
arm Group Labels
Placebo + pemetrexed/cisplatin
description
backbone chemo
name
Pemetrexed
type
DRUG
arm Group Labels
Nintedanib 200mg + pemetrexed/cisplatin
description
backbone chemo
name
Cisplatin
type
DRUG
arm Group Labels
Placebo + pemetrexed/cisplatin
description
backbone chemo
name
Cisplatin
type
DRUG
arm Group Labels
Nintedanib 200mg + pemetrexed/cisplatin
description
backbone chemo
name
Pemetrexed
type
DRUG
arm Group Labels
Placebo + pemetrexed/cisplatin
description
Nintedanib matching placebo
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE

primary Purpose

TREATMENT

Enrollment

count: 545
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
measure
Progression-Free Survival (PFS)
time Frame
From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)

secondary Outcomes

description
Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.
measure
Overall Survival (OS)
time Frame
From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
description
Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.
measure
Objective Response According to Modified RECIST- Investigator Assessment
time Frame
Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
description
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
measure
Disease Control According to Modified RECIST- Investigator Assessment
time Frame
Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

Full study description

brief Summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

Source references

references

citation
Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.
pmid
31103412
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-db2c79b23aad619d46f2
requested nct id
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primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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nct id
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occurrences
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exact text
NCT01907100
start
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offset unit
unicode_code_points
query cond
Malignant Mesothelioma
query disease state id
ds-malignant-mesothelioma
source file
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source file sha256
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice