NCT01098266 · REGISTRY CONDITION SEARCH

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

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

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-09-17

The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

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

Overall Survival (OS)

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Disease Control Rate (DCR)

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outcome · POSTED

Number of Partecipants With Disease Control for ≥ 6 Months

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outcome · POSTED

Number of Partecipants With Adverse Events

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outcome · POSTED

Time to LCSS Symptomatic Progression

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outcome · POSTED

Evaluation of Medical Care Utilization in the Two Treatment Arms

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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: * Age ≥ 18 years * Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown * Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin * ECOG Performance Status 0 - 2 * Life expectancy of ≥ 12 weeks * Adequate baseline bone marrow, hepatic and renal function, defined as follows: 1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL 2. Bilirubin ≤ 1.5 x ULN 3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis 4. Serum creatinine \< 1.5 x ULN * Measurable or non-measurable disease according to MPM-modified RECIST criteria * Patients may have had prior therapy providing the following conditions are met: 1. Surgery: wash-out period of 14 days 2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days * Patients must give written informed consent to participate in the study Exclusion Criteria: * Patients must not receive any other investigational agents while on study * Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Uncontrolled hypertension * QTc interval (congenital or acquired) \> 450 ms * History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke) * Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * Pregnancy or lactation
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
NGR-hTNF plus Best Investigator's Choice
intervention Names
Drug: NGR-hTNF plus Best Investigator's Choice (BIC)
label
A: NGR-hTNF + BIC
type
EXPERIMENTAL
description
Placebo plus Best Investigator's Choice
intervention Names
Drug: Placebo plus Best Investigator's Choice (BIC)
label
B: Placebo+BIC
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
A: NGR-hTNF + BIC
description
* NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
name
NGR-hTNF plus Best Investigator's Choice (BIC)
other Names
NGR-hTNF+BIC
type
DRUG
arm Group Labels
B: Placebo+BIC
description
* Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
name
Placebo plus Best Investigator's Choice (BIC)
other Names
Placebo+BIC
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 400
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
measure
Overall Survival (OS)
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months

secondary Outcomes

description
Defined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression
measure
Progression-Free Survival (PFS)
time Frame
From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 months
description
Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
measure
Disease Control Rate (DCR)
time Frame
Assessed every 6-12 weeks, up to 100 weeks
description
Measured from the date of randomization until disease progression, or death due to any cause
measure
Number of Partecipants With Disease Control for ≥ 6 Months
time Frame
Assessed every 6-12 weeks, up to 100 weeks
description
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
measure
Number of Partecipants With Adverse Events
time Frame
Assessed every 6-12 weeks, up to 100 weeks
description
Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.
measure
Time to LCSS Symptomatic Progression
time Frame
from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)
description
Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.
measure
Evaluation of Medical Care Utilization in the Two Treatment Arms
time Frame
Assessed every 6-12 weeks, up to 100 weeks

Full study description

brief Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
detailed Description: Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen. For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting. However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice. Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting. The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.

Source references

references

citation
Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.
pmid
29753703
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice