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Trial Summary

Protocol No.BAY94-9343
StatusOPEN TO ACCRUAL
Principal InvestigatorO'Neil, Bert
ScopeNational
PhasePhase I
Age GroupAdult
TitlePhase 1b Multi-indication Study of Anetumab Ravtansine (BAY 94-9343)in Patients with Mesothelin Expressing Advanced or Recurrent Malignancies
DescriptionThe key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • 18 years or older
  • Diagnosis of mesothelin-expressing metastatic or advanced non-metastatic disease
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesEsophageal Cancer (Gastrointestinal)
Esophageal Cancer (Thoracic)
Lung Cancer, Non-Small Cell
Lung Cancer, Small Cell
Pancreatic Cancer
Stomach (Gastric) Cancer
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment
ContactA. John Spittler, RNPhone: 317-274-0771
Pager: 317-312-1429
Email: ajspittl@iupui.edu