Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
NCT ID: NCT02709512
Last Updated: 2023-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
249 participants
INTERVENTIONAL
2017-08-01
2022-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Drug: ADI-PEG 20 plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study
In Combination With:
Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous
ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
ADI-PEG 20 plus Pem Platinum
Investigational Drug in combination approved standard of care treatment for this indication
Drug: Placebo plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study
In Combination With:
Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous
Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
Placebo plus Pem Platinum
Placebo in combination approved standard of care treatment for this indication
Interventions
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ADI-PEG 20 plus Pem Platinum
Investigational Drug in combination approved standard of care treatment for this indication
Placebo plus Pem Platinum
Placebo in combination approved standard of care treatment for this indication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve to chemotherapy or immunotherapy
* ECOG PS 0-1
* Expected survival of at least 3 months
* Age 18 years or over (there is no upper age limit)
* Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
* Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
* Adequate hematologic, hepatic, and renal function
Exclusion Criteria
* History of unstable cardiac disease
* Ongoing toxic manifestations of previous treatments
* Symptomatic brain or spinal cord metastases (patients must be stable for \> 1 month post radiotherapy or surgery)
* Major thoracic or abdominal surgery from which the patient has not yet recovered.
18 Years
ALL
No
Sponsors
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Polaris Group
INDUSTRY
Responsible Party
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Principal Investigators
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John S Bomalaski, MD
Role: STUDY_DIRECTOR
Polaris Group
Locations
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Mayo Clinic
Phoenix, Arizona, United States
UCLA Hematology & Oncology - Santa Monica
Los Angeles, California, United States
University of California San Francisco Helen Diller Comprehensive Cancer Center
San Francisco, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Maryland, Marlene & Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Tweed Hospital (NNSW LHD)
Tweed Heads, New South Wales, Australia
Princess Alexandria Hospital and Health Services
Woolloongabba, Queensland, Australia
Southern Adelaide Local Health Network, Inc.
Bedford Park, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, Italy
Humanitas Gavazzeni
Bergamo, BG, Italy
Ospedale Villa Scassi
Genova, GE, Italy
Azienda Ospedaliera San Gerardo - Monza, Chirurgia Toracica
Monza, MB, Italy
European Institute of Oncology
Milan, MI, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori Milano
Milan, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Foundation LinKou Branch
Taoyuan District, , Taiwan
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Plymouth Hospitals (Derriford Hospital)
Plymouth, Devon, United Kingdom
Centre for Experimental Cancer Medicine (CECM)
London, England, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
University Hospitals Leicester
Leicester, Leicestershire, United Kingdom
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, United Kingdom
Wansbeck General Hospital
Ashington, Northumberland, United Kingdom
Oxford Cancer and Haematology Centre, The Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Edinburgh Cancer Centre
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University Hospital of South Manchester
Manchester, , United Kingdom
Countries
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References
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Szlosarek PW, Creelan BC, Sarkodie T, Nolan L, Taylor P, Olevsky O, Grosso F, Cortinovis D, Chitnis M, Roy A, Gilligan D, Kindler H, Papadatos-Pastos D, Ceresoli GL, Mansfield AS, Tsao A, O'Byrne KJ, Nowak AK, Steele J, Sheaff M, Shiu CF, Kuo CL, Johnston A, Bomalaski J, Zauderer MG, Fennell DA; ATOMIC-Meso Study Group. Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma: The ATOMIC-Meso Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):475-483. doi: 10.1001/jamaoncol.2023.6789.
Szlosarek PW, Phillips MM, Pavlyk I, Steele J, Shamash J, Spicer J, Kumar S, Pacey S, Feng X, Johnston A, Bomalaski J, Moir G, Lau K, Ellis S, Sheaff M. Expansion Phase 1 Study of Pegargiminase Plus Pemetrexed and Cisplatin in Patients With Argininosuccinate Synthetase 1-Deficient Mesothelioma: Safety, Efficacy, and Resistance Mechanisms. JTO Clin Res Rep. 2020 Sep 3;1(4):100093. doi: 10.1016/j.jtocrr.2020.100093. eCollection 2020 Nov.
Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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POLARIS2015-003
Identifier Type: -
Identifier Source: org_study_id
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