Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM (NVB Metro)

November 15, 2022 updated by: Assistance Publique Hopitaux De Marseille

Phase IA/IB of Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With Non Small Cell Lung Cancer or Malignant Pleural Mesothelioma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Assistance Publique des Hôpitaux de Marseille (CEPCM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (male or female) ≥ 18 years of age.
  • Patients with histologically documented, locally advanced or recurrent (stage IIIB) or metastatic (Stage IV) non-small cell lung Cancer or malignant pleural mesothelioma, for which no standard exits.
  • Presence of at least one measurable lesion according to RECIST v.1.1 for NSCLC and modified RECIST 1.1 for MPM
  • ECOG performance status ≤2

Exclusion Criteria:

  • ECOG performance status >2
  • Patients with significant or uncontrolled cardiovascular disease (eg, congestive heart failure, angor, arrhythmia) within 6 months of starting study treatment
  • Any neurological or psychiatric condition interfering with the understanding of study
  • Infectious condition uncontrolled
  • Any other medical condition that would jeopardize the subject participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Vinorelbine
Drug: Vinorelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Participants will be followed for the a maximum period of 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Director, Assistance Publique Des Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2015

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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