Clinical Trial 18517

Cancer Type: Thoracic
Interventions:Anetumab Ravtansine (BAY 94-9343); Navelbine (Vinorelbine); Vinorelbine

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Tawee Tanvetyanon

Overview

Study Title

A Randomized, Open-Label, Active-Controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients with Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-Based Chemotherapy

Summary

The main purpose of the 15743 study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in mesothelioma patients with mesothelin overexpression.

Objective

The primary objective of this study is to: Test the superiority of anetumab ravtansine monotherapy over vinorelbine in progression-free survival (PFS). The secondary objectives of this study are to: Test overall survival (OS). Evaluate pulmonary function. Evaluate patient-reported outcomes(PROs), symptom burden and health-related quality of life. Evaluate other indicators of treatment efficacy (indicators of tumor response). Evaluate safety. The other objectives of this study are to evaluate the: Pharmacokinetics (PK). Immunogenicity. Biomarkers.

Inclusion Criteria

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  • Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
  • Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed
  • Must have measurable disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function
  • Left ventricular ejection fraction (LVEF) ≥ 50% or the lower limit of normal (LLN) according to local institution ranges of normality

  • Exclusion Criteria

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  • More than 1 previous systemic anti-cancer therapy line
  • Potential participants with corneal epitheliopathy or any eye disorder that may predispose the participants to this condition at the discretion of the ophthalmologist.
  • Symptomatic brain metastases or meningeal tumors or other uncontrolled metastases in the central nervous system (CNS)
  • Evidence of history of bleeding diathesis.
  • Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.
  • Pre-existing cardiac conditions