NCT02709512

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

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Mesothelioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-01
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2016-03-16
• Last updated: 2023-10-04
• Results posted: 2023-10-04

Locations

45 sites across 5 countries: United States, Australia, Italy, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study