Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
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.
Checked against the public recordLast updated Oct 4, 2023 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.