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Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO)

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ClinicalTrials.gov Identifier: NCT02863055
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: Nintedanib Drug: Placebo Phase 2

Detailed Description:

This is a multicenter, prospective, double blinded, randomized, two-arm phase II trial aiming to evaluate nintedanib treatment as switch maintenance in patients with unresectable MPM.

After signing of the informed consent and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:

  • Arm A: twice daily nintedanib at a dose of 200 mg until progression or unacceptable toxicities.
  • Arm B: matched placebo.

Response evaluation will be performed through CT scans every 8 weeks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group
Actual Study Start Date : February 4, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Nintedanib
200 mg twice a day per os
Drug: Nintedanib
Nintedanib 200 mg administered twice daily

Placebo Comparator: Placebo
Placebo match twice a day per os
Drug: Placebo
Matching placebo administered twice daily




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months ]
    From randomization until progression or death


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    From randomization until progression or death

  2. Overall Response Rate [ Time Frame: 6 months ]
    Response according to modified RECIST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of unresectable Malignant Pleural Mesothelioma (MPM);
  • Response or Stable disease according to modified RECIST criteria [48] after first line platinum-pemetrexed chemotherapy for 4-6 cycles;
  • Last platinum chemotherapy dose administered within 60 days (i.e. randomization must occur within 60 days from the last dose of the last cycle of platinum-pemetrexed chemotherapy);
  • Age >18 years;
  • ECOG performance status (PS) 0-2;
  • Life expectancy of at least 12 weeks in the opinion of the investigator;
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose

Exclusion Criteria:

  • prior systemic anticancer therapy including cytotoxic therapy or immune-checkpoint inhibitor, for MPM, other than first line platinum-based doublet chemotherapy;
  • previous extra-pleural pneumonectomy (other forms of previous surgery eg pleurectomy are acceptable);
  • previous Vascular Endothelial Growth Factor (VEGF) inhibitors (eg bevacizumab, sorafenib, etc);
  • treatment with other investigational drugs or treatment in another clinical interventional trial within the past 4 weeks before start of therapy or concomitantly with the trial;
  • patients that, in the opinion of the investigator, have reduced performance status by 2 ECOG levels (e.g. PS 0 to 2 or PS 1 to 3) from beginning to completion of 1st line chemotherapy;
  • radiotherapy (with the exception of palliative radiotherapy) during study or within 4 weeks of start of study drug;
  • known brain metastasis or lepto-meningeal disease. Patients with suspicious neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasisNo active brain metastases (e.g. stable for < 4 weeks;, no adequate previous treatment with radiotherapy;, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization); patients with suspicious neurological symptoms should undergo a CT scan/MRI of the brain to assess brain metastasis;
  • leptomeningeal metastases;
  • significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial;
  • pre-existing clinically significant ascites and/or clinically significant pleural effusion;
  • active or history of bleeding complications that would prevent anti-angiogenic therapy
  • centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels; typical mediastinal pleural involvement with mesothelioma remains eligible;
  • clinically active cancer other than mesothelioma within 5 years prior to start of study treatment;
  • radiographic evidence of cavitatory or necrotic tumors;
  • unstoppable use of therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =325mg per day);
  • clinically significant cardiovascular diseases (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive New York Heart Association (NYHA) II, serious cardiac arrhythmia, clinically significant pericardial effusion)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863055


Contacts
Contact: EORTC HQ +32 2 774 1611 08112@eortc.org

Locations
Belgium
UZ Antwerpen Recruiting
Antwerpen, Belgium
Contact: Jan Van Meerbeeck, prof         
UZ Gent Recruiting
Gent, Belgium
Contact: Veerle Surmont, Prof         
Italy
Ospedale San Paolo Recruiting
Milan, Italy
Contact: Andrea Luciani, Dr         
United Kingdom
Manchester University NHS Foundation Trust - UHSM-Wythenshawe Hospital Recruiting
Wythenshawe, Manchester, United Kingdom, M23 9LT
Principal Investigator: Paul Taylor         
Royal Marsden Hospital Recruiting
Chelsea, United Kingdom
Contact: Sanjay Popat, Dr         
Royal Marsden Hospital - Kingston Recruiting
Kingston, United Kingdom
Contact: Sanjay Popat, Dr         
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital Recruiting
Sheffield, United Kingdom
Contact: Robin Young, Dr         
NHS South Tyneside-South Tyneside District Hospital Recruiting
South Shields, United Kingdom
Contact: Rhona McMenemin, Dr         
Royal Marsden Hospital Recruiting
Sutton, United Kingdom
Contact: Sanjay Popat, Dr         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Sanjay Popat, PhD, MD Royal Marsden NHS Foundation Trust
Principal Investigator: Omar Abdel-Rahman, MD Ain Shams University

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02863055     History of Changes
Other Study ID Numbers: EORTC-08112
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
MPM
Unresectable
Phase II
Randomized
Maintenance

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action