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CompletedPhase 2 / Phase 3NCT02709512
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedADI-PEG 20 plus Pem Platinum and Placebo plus Pem Platinum

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 4, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?45 U.S. locations

Locations may change over time.

Who runs it?Polaris Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Polaris Group
Interventions being studied
Drug: ADI-PEG 20 plus Pem Platinum; Other: Placebo plus Pem Platinum
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo ClinicPhoenix, Arizona
  • UCLA Hematology & Oncology - Santa MonicaLos Angeles, California
  • University of California San Francisco Helen Diller Comprehensive Cancer CenterSan Francisco, California
  • H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
  • University of ChicagoChicago, Illinois
  • University of Maryland, Marlene & Stewart Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
  • Henry Ford HospitalDetroit, Michigan
  • Mayo ClinicRochester, Minnesota
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • MD Anderson Cancer CenterHouston, Texas
  • Chris O'Brien LifehouseCamperdown, New South Wales
  • Tweed Hospital (NNSW LHD)Tweed Heads, New South Wales

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2023. Always confirm current availability with the study team.

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