Atomic

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Brief Summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate synthetase 1 expression. 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.

Study Type
Interventional

Study Phase
Phase 2
Phase 3

Study Design
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Intervention
• Drug: ADI-PEG 20 plus Pem Cis

Investigational Drug in combination approved standard of care treatment for this indication
Other Names:
• Pemetrexed
• Cisplatin

• Other: Placebo plus Pem Cis

Placebo in combination approved standard of care treatment for this indication
Other Names:
• Pemetrexed
• Cisplatin

Study Arms
• Experimental: Drug: ADI-PEG 20 plus Pem Cis

Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study
In Combination With:
Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous
Intervention: Drug: ADI-PEG 20 plus Pem Cis

• Placebo Comparator: Drug: Placebo plus Pem Cis

Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study
In Combination With:
Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous
Intervention: Other: Placebo plus Pem Cis

Sponsors
Polaris Group

Collaborators
Not provided

Principal Investigators
Study Director:     John S Bomalaski, MD     Polaris

Recruitment start: 01/10/2016
Recruitment end: 01/06/2018

Contact
Phuong Lee     858-452-6688 ext 188     plee@polarispharma.com