Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Mesothelioma

In brief

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. 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.

Key facts

Study ID

NCT02709512

Run by

Polaris Group

People needed

249

Starts

2017-08-01

Expected to finish

2022-08-15

Last updated by the study team

2023-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven unresectable MPM of biphasic or sarcomatoid histology
• 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

You may not qualify if…

• Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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