Trial Condition(s):

Mesothelioma

Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)

Bayer Identifier:

15743

ClinicalTrials.gov Identifier:

NCT02610140

EudraCT Number:

2012-003650-88

Study Completed

Trial Purpose

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).
210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.
Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.
Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.

Inclusion Criteria
- 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.
 - Patients 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
- More than 1 previous systemic anti-cancer therapy line 
 - Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the investigator in consultation with the
ophthalmologist.
 - Brain metastases, meningeal tumours or other metastases in the central nervous system
 - 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

Trial Summary

Enrollment Goal
248
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10043

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24125

Status
Completed
 
Locations

Investigative Site

Monza Brianza, Italy, 20900

Status
Completed
 
Locations

Investigative Site

Pordenone, Italy, 33081

Status
Completed
 
Locations

Investigative Site

Siena, Italy, 53100

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Investigative Site

Bethesda, United States, 20814

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75251

Status
Completed
 
Locations

Investigative Site

New Orleans, United States, 70121

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60637

Status
Completed
 
Locations

Investigative Site

Nedlands, Australia, 6009

Status
Completed
 
Locations

Investigative Site

Woolloogabba, Australia, 4102

Status
Completed
 
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Investigative Site

London, United Kingdom, SE1 9RT

Status
Completed
 
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Investigative Site

Adelaide, Australia, 5043

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
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Investigative Site

Madrid, Spain, 28041

Status
Completed
 
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Investigative Site

A Coruña, Spain, 15006

Status
Completed
 
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Investigative Site

Richmond, Australia, 3122

Status
Completed
 
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Investigative Site

Calgary, Canada, T2N 4N2

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
 
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Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
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Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
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Investigative Site

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
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Investigative Site

Plymouth, United Kingdom, PL6 8DH

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M23 9LT

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-952

Status
Completed
 
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Investigative Site

Szczecin, Poland, 70-891

Status
Completed
 
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Investigative Site

Alicante, Spain, 03010

Status
Completed
 
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Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1066 CX

Status
Completed
 
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Investigative Site

St Leonards, Australia, 2065

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey, 06100

Status
Completed
 
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Investigative Site

Vaasa, Finland, 65130

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00290

Status
Completed
 
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Investigative Site

Turku, Finland, 20520

Status
Completed
 
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Investigative Site

Malatya, Turkey, 44280

Status
Completed
 
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Investigative Site

Istanbul, Turkey, 34899

Status
Completed
 
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Investigative Site

Adana, Turkey, 01330

Status
Completed
 
Locations

Investigative Site

Yenimahalle, Turkey, 06200

Status
Completed
 
Locations

Investigative Site

Tampa, United States, 33612

Status
Completed
 
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Investigative Site

Norwich, United States, 06360

Status
Completed
 
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Investigative Site

La Jolla, United States, 92093-1503

Status
Completed
 
Locations

Investigative Site

Lille Cedex, France, 59037

Status
Completed
 
Locations

Investigative Site

PIERRE BENITE, France, 69495

Status
Completed
 
Locations

Investigative Site

BORDEAUX CEDEX, France, 33076

Status
Terminated
 
Locations

Investigative Site

PARIS, France, 75020

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-202

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-501

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60612

Status
Completed
 
Locations

Investigative Site

Buffalo, United States, 14263-0001

Status
Completed
 
Locations

Investigative Site

New York, United States, 10016

Status
Terminated
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Completed
 
Locations

Investigative Site

Yekaterinburg, Russia, 620036

Status
Completed
 
Locations

Investigative Site

Omsk, Russia, 644013

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 4L6

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27710

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13915

Status
Completed
 
Locations

Investigative Site

Málaga, Spain, 29010

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20133

Status
Completed
 
Locations

Investigative Site

SINT-NIKLAAS, Belgium, 9100

Status
Completed
 
Locations

Investigative Site

Maidstone, United Kingdom, ME16 9QQ

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G12 0YN

Status
Completed
 
Locations

Investigative Site

Eskisehir, Turkey, 26480

Status
Completed
 
Locations

Investigative Site

CAEN CEDEX 5, France, 14076

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75018

Status
Terminated
 

Trial Design