A Phase 1 interventional study of Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Malignant Pleural Mesothelioma (MPM), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 1, Interventional, and Treatment
Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant Pleural Mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.
Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the calibration of the average parameters of the model. Depending the phase Ia result, and after favorable decision of a consultative committee, the extension phase (phase Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.
An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.
Discussion: this ongoing trial is the first to prospectively test a mathematical optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
Drug: Vinorelbine
Phase IA : Treatment-related hematological toxicities (neutropenia) of grade 3-4 as assessed by CTCAE v4.0
Time frame: Participants will be followed for the a maximum period of 24 months.
Phase IB : Objective response rate according to RECIST1.1 for NSCLC and RECIST1.1 modified for MPM
Time frame: Participants will be followed for the a maximum period of 24 months.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille