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