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

NCT02709512 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2023-10-04

Study results available
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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.

Conditions

Interventions

DRUG

ADI-PEG 20 plus Pem Platinum

Investigational Drug in combination approved standard of care treatment for this indication

OTHER

Placebo plus Pem Platinum

Placebo in combination approved standard of care treatment for this indication

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • John S Bomalaski, MD · Polaris Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-08-15
Completion
2022-08-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Italy
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02709512 on ClinicalTrials.gov