Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
NCT ID: NCT02610140
Last Updated: 2020-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2015-12-03
2019-09-06
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAY94-9343
Drug Anetumab ravtansine given Intravenously (IV)
Anetumab ravtansine (BAY94-9343)
Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
Vinorelbine
Drug Vinorelbine given Intravenously
Vinorelbine
Starting dose: 30mg/m\^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.
Interventions
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Anetumab ravtansine (BAY94-9343)
Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
Vinorelbine
Starting dose: 30mg/m\^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ImmunoGen and MorphoSys
UNKNOWN
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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La Jolla, California, United States
Aurora, Colorado, United States
Norwich, Connecticut, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Bethesda, Maryland, United States
Rochester, Minnesota, United States
Buffalo, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Dallas, Texas, United States
Houston, Texas, United States
St Leonards, New South Wales, Australia
Woolloogabba, Queensland, Australia
Adelaide, South Australia, Australia
Richmond, Victoria, Australia
Nedlands, Western Australia, Australia
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Sint-Niklaas, , Belgium
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Helsinki, , Finland
Turku, , Finland
Vaasa, , Finland
Bordeaux, , France
Caen, , France
Lille, , France
Marseille, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Pordenone, Friuli Venezia Giulia, Italy
Bergamo, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Monza Brianza, Lombardy, Italy
Turin, Piedmont, Italy
Siena, Tuscany, Italy
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Gdansk, , Poland
Krakow, , Poland
Krakow, , Poland
Szczecin, , Poland
Omsk, , Russia
Yekaterinburg, , Russia
Seoul, , South Korea
Seoul, , South Korea
A Coruña, , Spain
Alicante, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Eskişehir, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Malatya, , Turkey (Türkiye)
Yenimahalle, , Turkey (Türkiye)
Plymouth, Devon, United Kingdom
Maidstone, Kent, United Kingdom
Leicester, Leicestershire, United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Kindler HL, Novello S, Bearz A, Ceresoli GL, Aerts JGJV, Spicer J, Taylor P, Nackaerts K, Greystoke A, Jennens R, Calabro L, Burgers JA, Santoro A, Cedres S, Serwatowski P, Ponce S, Van Meerbeeck JP, Nowak AK, Blumenschein G Jr, Siegel JM, Kasten L, Kochert K, Walter AO, Childs BH, Elbi C, Hassan R, Fennell DA. Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial. Lancet Oncol. 2022 Apr;23(4):540-552. doi: 10.1016/S1470-2045(22)00061-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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2012-003650-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15743
Identifier Type: -
Identifier Source: org_study_id