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The Latest Clinical Trial for Nintedanib – Are You a Candidate?

Published: February 24, 2017

Scientists and researchers are excited over the latest completion of a Phase II clinical trial for those suffering from mesothelioma – an incurable asbestos-caused cancer that has a median survival of only 9 to 12 months.  The LUME-Meso Phase II trial for patients with malignant pleural mesothelioma showed a slight increase in progression-free and overall survival with the administration of nintedanib along with chemotherapy treatments pemetrexed and cisplatin.

Nintedanib is an oral triple angiokinase inhibitor.  This means it blocks cancer growth by hindering protein kinases in cancer cells and stops cancer cells from growing their own blood vessels.  Phase II completion showed the clinical trial met its goal for progression-free survival. Progression-free survival is the amount of time after treatment that a patient endures where the cancer or illness is still present, but has not advanced further. When nintedanib was added to chemotherapy treatments pemetrexed and cisplatin, progression-free survival rates improved from 5.7 months to 9.4 months. Overall survival improved from 14.5 months to 18.3 months.

Phase III requirements are now under way and nintedanib will be compared with other current treatment standards.  Patients are currently being recruited worldwide.

Read more about the Phase II trial

Eligibility for Clinical Trials
Eligibility for mesothelioma clinical trials are often specific to age, how long it has been since therapy, the stage of disease, and other characteristics. Trial participants must fit a certain profile to ensure that the study results are accurate. Selecting patients to be part of a clinical trial for mesothelioma is a process in its own, and recently researchers in London have developed a new way in categorizing those looking to participate.

The team of researchers evaluated the results of 38 Phase I trials between 2003 and 2015 specifically looking at response rates, survival between relapses, and overall survival. The current prognostic scoring system measures the blood protein called albumin, the number of disease sites, and the lactate dehydrogenase (LDH) level.  After evaluating the 38 Phase I trials, researchers found that those who developed advanced mesothelioma had a LDH level greater than 3, two or more disease sites, and albumin levels less than 35. This lead to the development of a point system in which one point was assigned to each of these factors. Patients with only one factor had a much higher overall survival rate than those with two or even three factors.  Researchers are hopeful that this scoring system will allow them to determine who will benefit the most from clinical trials.

 

Sources
PR Newswire, “Clinically meaningful data for oral nintedanib in mesothelioma presented at World Conference on Lung Cancer,” Boehringer Ingelheim Pharmaceuticals, Inc (December 7, 2016). [Link]

Papadatos-Pastos, D, et al, “Clinical outcomes and prognostic factors of patients with advanced mesothelioma treated in a phase I clinical trials unit”, European Journal of Cancer (February 16, 2017). [Link]

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