8 completed, 3 recruiting, 3 terminated, 3 withdrawn. 21 Phase 2, 6 Phase 1, 2 Phase 3.
Follow ADI PEG20: new trials by email Literature Review of ADI PEG20 trials Research Report on ADI PEG20
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG) ADI-PEG 20 (Arginine deiminase pegylated), Temozolomide (TMZ), Standard of Care Radiation Therapy (RT) - Glioblastoma, High-Grade Glioma (WHO III-IV) | Phase 1 / Phase 2 | Not yet recruiting | Sabine Mueller, MD, PhD | 97 | 2027-06-01 | 2026-11-09 |
| ADI-PEG20, Obesity and Prediabetes ADI-PEG20, Placebo - Obesity, PreDiabetes | Phase 2 | Withdrawn | Washington University School of Medicine | 2024-04-01 | 2024-11-07 | |
| Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) ADI-PEG 20, Cabazitaxel, Carboplatin - Prostate Cancer | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 30 | 2024-02-29 | 2026-09-18 |
| Phase 2 Study of ADI-PEG 20 Plus Lenvatinib Treatment in Subjects With Unresectable Hepatocellular Carcinoma ADI-PEG20 - Hepatocellular Carcinoma | Phase 2 | Unknown | Chang Gung Memorial Hospital | 120 | 2023-12-01 | 2023-09-13 |
| Study of ADI-PEG 20 Versus Placebo in Subjects With NASH ADI-PEG20, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Recruiting | Polaris Group | 60 | 2023-09-13 | 2025-09-23 |
| A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma Atezolizumab, Bevacizumab, ADI-PEG 20 - Metastatic Hepatocellular Carcinoma | Phase 1 / Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2023-08-08 | 2024-08-26 | |
| ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers ADI-PEG 20, Gemcitabine, Docetaxel - Non Small Cell Lung Cancer, Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | Washington University School of Medicine | 31 | 2023-04-05 | 2026-07-27 |
| Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer Nivolumab, Pegargiminase, Resection - Resectable Hepatocellular Carcinoma | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2022-04-13 | 2023-02-16 | |
| ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme ADI-PEG 20, Temozolomide, Placebo - Glioblastoma Multiforme (GBM) | Phase 2 | Active not recruiting | Polaris Group | 100 | 2020-09-14 | 2025-08-26 |
| A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma Temozolomide, Lomustine, Regorafenib - Glioblastoma | Phase 2 / Phase 3 | Recruiting | Global Coalition for Adaptive Research | 2250 | 2019-07-30 | 2026-11-02 |
| ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer pegylated arginine deiminase, Gemcitabine, Docetaxel - Soft Tissue Sarcoma | Phase 2 | Completed | Washington University School of Medicine | 98 | 2018-05-09 | 2025-12-11 |
| Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum - Mesothelioma | Phase 2 / Phase 3 | Completed | Polaris Group | 249 | 2017-08-01 | 2023-10-04 |
| PH 2 ADI-PEG 20 Acute Myeloid Leukemia ADI-PEG 20 - Acute Myeloid Leukemia | Phase 2 | Completed | Polaris Group | 43 | 2015-01-06 | 2020-10-01 |
| Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma ADI-PEG 20 plus modified FOLFOX6 - Advanced Gastrointestinal (GI) Malignancies, Hepatocellular Carcinoma | Phase 1 / Phase 2 | Terminated | Polaris Group | 140 | 2014-11-01 | 2022-04-25 |
| Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma ADI-PEG 20, Transarterial chemoembolization - Unresectable Hepatocellular Carcinoma | Phase 2 | Completed | Polaris Group | 30 | 2014-10-15 | 2018-09-04 |
| PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy ADI-PEG 20 - Non-Hodgkin's Lymphoma | Phase 2 | Completed | Polaris Group | 18 | 2013-12-06 | 2018-09-18 |
| A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma ADI-PEG 20 - Malignant Pleural Mesothelioma | Phase 2 | Unknown | Barts & The London NHS Trust | 70 | 2011-01-01 | 2014-11-20 |
| Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer ADI-PEG 20 (Arginine deiminase pegylated) - Small Cell Lung Cancer | Phase 2 | Terminated | Ludwig Institute for Cancer Research | 22 | 2011-01-01 | 2022-10-25 |
| Study of ADI-PEG 20 in Patients With Advanced Melanoma ADI PEG 20 - Metastatic Melanoma, Skin Cancer | Phase 1 / Phase 2 | Completed | Ludwig Institute for Cancer Research | 31 | 2007-07-01 | 2022-10-25 |
| Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery ADI-PEG-20, Pharmacology Studies - Melanoma (Skin) | Phase 2 | Completed | University of Miami | 38 | 2004-06-01 | 2017-02-08 |
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Carcinoma, Hepatocellular (4) · Glioblastoma (3) · Melanoma (2) · Mesothelioma, Malignant (2) · Neoplasms (2) · Small Cell Lung Carcinoma (2) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Glioma (1) · Leukemia, Myeloid, Acute (1) · Liver Neoplasms (1) · Lymphoma, Non-Hodgkin (1) · Mesothelioma (1) · Non-alcoholic Fatty Liver Disease (1) · Obesity (1)
Polaris Group (7) · M.D. Anderson Cancer Center (3) · Washington University School of Medicine (3) · Ludwig Institute for Cancer Research (2) · Barts & The London NHS Trust (1) · Chang Gung Memorial Hospital (1) · FDA Office of Orphan Products Development (1) · Global Coalition for Adaptive Research (1) · Sabine Mueller, MD, PhD (1) · University of Miami (1)
United States (15) · Taiwan (9) · United Kingdom (4) · Australia (2) · Germany (2) · Italy (2) · South Korea (2) · Belgium (1) · Canada (1) · China (1) · France (1) · Switzerland (1)
Ana Aparicio, MD (1) · Anna Pavlick, DO (1) · Christine Auberle, M.D. (1) · Gary Schwartz, MD (1) · James Harding, MD (1) · Jedd Wolchok, MD, PhD (1) · John S Bomalaski (1) · John S Bomalaski, MD (1) · Kuo-Chen Wei, M.D. (1) · Lee M Krug, MD (1) · Lynn G. Feun, MD (1) · Mia Weiss, M.D. (1) · Pei-Jer Chen, MD, PhD (1) · Peter Szlosarek (1) · Sabine Mueller, MD, PhD (1)
PMID 22472884, PMID 22864522, PMID 27584578, PMID 28900115, PMID 33358660, PMID 34589965, PMID 38358753, PMID 38773224, PMID 41980234
R01CA227115 (1)