Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma (NCT02863055) | Clinical Trial Compass
TerminatedPhase 2
Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma
Stopped: lack of scientific relevance (change in the treatment landscape) and poor recruitment
Belgium, Italy, United Kingdom37 participantsStarted 2018-02-04
Plain-language 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
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 excepti…
What they're measuring
1
Progression-free survival
Timeframe: 6 months
Trial details
NCT IDNCT02863055
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC