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Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC)

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ClinicalTrials.gov Identifier: NCT02709512
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Polaris Group

Brief Summary:
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: ADI-PEG 20 plus Pem Cis Other: Placebo plus Pem Cis Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Drug: ADI-PEG 20 plus Pem Cis

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

Drug: ADI-PEG 20 plus Pem Cis
Investigational Drug in combination approved standard of care treatment for this indication
Other Names:
  • Pemetrexed
  • Cisplatin

Placebo Comparator: Drug: Placebo plus Pem Cis

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

Other: Placebo plus Pem Cis
Placebo in combination approved standard of care treatment for this indication
Other Names:
  • Pemetrexed
  • Cisplatin




Primary Outcome Measures :
  1. Response Rate [ Time Frame: approximately 18 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: approximately 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
  2. Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
  3. MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
  4. Measurable disease as assessed by modified RECIST for MPM for thoracic disease (Appendix A) and RECIST 1.1 for extra-thoracic disease (Appendix B).
  5. ECOG performance status of 0 - 1 (Appendix C).
  6. Predicted life expectancy of at least 12 weeks.

Exclusion Criteria:

  1. Radiotherapy (except for palliative reasons) the previous two weeks before.
  2. Ongoing toxic manifestations of previous treatments.
  3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
  4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
  5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
  6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709512


Contacts
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Contact: Sonia Doyle 858-452-6688 ext 189 sdoyle@polarispharma.com
Contact: Sandra Dodd 858-452-6688 ext 188 sdodd@polarispharma.com

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Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Helen Ross, MD         
United States, California
UCLA Hematology & Oncology - Santa Monica Recruiting
Los Angeles, California, United States, 90095
Contact: Olga Olvesky, MD         
University of California San Francisco Helen Diller Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Thierry Jahan, MD         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Alberto Chiappori, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hedy Kindler, MD         
United States, Maryland
University of Maryland, Marlene & Stewart Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ken Miller, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Igor Rybkin, MD PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Aaron Mansfield, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Marjorie Zauderer, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anne S Tsao, M.D.         
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Steven Kao, MD         
Tweed Hospital (NNSW LHD) Recruiting
Tweed Heads, New South Wales, Australia, 2486
Contact: Ehtesham Abdi, Prof         
Australia, Queensland
Princess Alexandria Hospital and Health Services Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Ken O'Byrne, Prof         
Australia, South Australia
Southern Adelaide Local Health Network, Inc. Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Christos Karapetis, Prof         
Australia, Victoria
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Thomas John, MD         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia, 6009
Contact: Anna Nowak, MD         
Italy
SS. Antonio e Biagio e Cesare Arrigo Hospital Recruiting
Alessandria, AL, Italy, 15121
Contact: Federica Grosso, MD         
Humanitas Gavazzeni Recruiting
Bergamo, BG, Italy, 24125
Contact: Giovanni Luca Ceresoli         
Ospedale Villa Scassi Recruiting
Genova, GE, Italy, 16149
Contact: Manlio Mencoboni, MD         
Azienda Ospedaliera San Gerardo - Monza, Chirurgia Toracica Recruiting
Monza, MB, Italy, 20900
Contact: Diego Luigi Cortinovis         
European Institute of Oncology Recruiting
Milano, MI, Italy, 20141
Contact: Filippo De Marinis, MD         
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, PV, Italy, 27100
Contact: Giula Maria Stella, MD         
Fondazione IRCCS - Istituto Nazionale dei Tumori Milano Recruiting
Milan, Italy, 20133
Contact: Nicoletta Zilembo, MD         
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, Italy, 43126
Contact: Marcello Tiseo, MD         
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56124
Contact: Antonio Chella, MD         
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Inn-Wen Chong         
Chang Gung Medical Foundation Kaohsiung Recruiting
Kaohsiung, Taiwan, 83301
Contact: Chin-Chou Wang, MD         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
Contact: Gee-Chen Chang, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Jang-Ming Lee, MD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Yuh-Min Chen, MD         
Chang Gung Memorial Foundation LinKou Branch Recruiting
Taoyuan, Taiwan, 33305
Contact: Cheng-Ta Yang, MD         
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Contact: David Gilligan, MD         
Plymouth Hospitals (Derriford Hospital) Recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact: Amy Roy, MD         
Centre for Experimental Cancer Medicine (CECM) Recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Peter Szlosarek, M.D. PhD         
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: David Nolam, MD         
University Hospitals Leicester Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Dean Fennell, MD         
Scunthorpe General Hospital Recruiting
Scunthorpe, North Lincolnshire, United Kingdom, DN15 7BH
Contact: Nabil El-Mahdawi, MD         
Wansbeck General Hospital Recruiting
Ashington, Northumberland, United Kingdom, NE63 9JJ
Contact: Paula Mulvenna, MD         
Oxford Cancer and Haematology Centre, The Churchill Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Meenali Chitnis, MD         
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Jason Lester, MD         
Edinburgh Cancer Centre Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Melanie MacKean, MD         
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Nicola Steele, MD         
St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Kevin Franks, MD         
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Peter Szlosarek, MD         
University Hospital of South Manchester Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Paul Taylor, MD         
Sponsors and Collaborators
Polaris Group
Investigators
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Study Director: John S Bomalaski, MD Polaris Group

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Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT02709512     History of Changes
Other Study ID Numbers: POLARIS2015-003
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polaris Group:
Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors