Table 1.
Trials Examining Arginine-Deprivation in Cancer Patients
| Trial | Status | Subjects (enrollment) |
Phase | Therapy | Findings or Primary Endpoint |
|---|---|---|---|---|---|
| Izzo et al73 | Completed | HCC (n=19) |
1/2 | PEG-ADI | PEG-ADI well-tolerated, possible efficacy |
| NCT0045037246 | Completed | Metastatic Melanoma (n=38) |
1/2 | PEG-ADI | Tumor AS expression predicted drug resistance and progression |
| NCT000569922 | Completed | HCC (n=80) |
2 | PEG-ADI | PEG-ADI antibodies developed at 4 weeks and correlated with increasing plasma arginine |
| NCT01910025 | Completed | Non-Hodgkin’s Lymphoma (n=18) |
2 | PEG-ADI | Results Pending – patients had previously failed medical therapy |
| NCT01910012 | Ongoing | Acute Myeloid Leukemia (n=43) |
2 | PEG-ADI | Response Rate |
| NCT01665183 | Ongoing | Metastatic Melanoma (n=8) |
1 | PEG-ADI + Cisplatin | Number of participants with adverse events |
| NCT01287585 | Ongoing | Advanced HCC with Prior Failed Medical Therapy (n=636) |
3 | PEG-ADI | Overall Survival vs. Placebo |
| NCT01266018 | Ongoing | Relapsed Sensitive or Refractory Small Cell Lung Cancer (n=45) |
2 | PEG-ADI | Efficacy at 4 weeks |
| NCT01528384 | Ongoing | Any AS-deficient Pediatric Cancer (n=8) |
1 | PEG-ADI | Safety Monitoring |
| NCT02029690 | Ongoing | Arginine Auxotrophic Cancers (n=88) |
1 | PEG-ADI + Pemetrexed & Cisplatin | Safety Monitoring / Estimates of Efficacy |
| NCT02285101 | Ongoing | Advanced Arginine Auxotrophic Tumors (n=36) |
1 | Arginase-1 (recombinant human Arg1) | Number of participants with adverse events |
Abbreviations: PEG, polyethylene glycol; HCC, hepatocellular carcinoma; ADI, arginine deiminase; AS, argininosuccinate synthetase