11 completed, 8 terminated, 3 recruiting, 2 active not recruiting. 14 Phase 1, 10 Phase 2, 5 Phase 3.
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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 |
|---|---|---|---|---|---|---|
| Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma ADI PEG20, Ifosfamide, Radiotherapy - Soft Tissue Sarcoma, Sts | Phase 1 | Terminated | Washington University School of Medicine | 6 | 2024-03-14 | 2026-09-03 |
| Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC) ADI PEG20, Placebo - Soft Tissue Sarcoma | Phase 3 | Terminated | Polaris Group | 218 | 2023-11-29 | 2026-06-25 |
| 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 |
| 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 |
| Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia ADI-PEG 20 - Acute Myeloid Leukemia, Adult | Phase 1 | Active not recruiting | Polaris Group | 38 | 2022-04-05 | 2026-10-15 |
| Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma ADI-PEG20, Placebo - Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma | Phase 3 | Recruiting | Polaris Group | 300 | 2022-03-14 | 2025-12-18 |
| 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 | 2026-10-01 |
| Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin Atezolizumab, Pemetrexed, Carboplatin - Carcinoma, Non-Small-Cell Lung | Phase 1 | Withdrawn | Queen Mary University of London | 2018-06-01 | 2020-02-25 | |
| 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 |
| Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers ADI PEG20, Pembrolizumab - Advanced Solid Cancers | Phase 1 | Terminated | Polaris Group | 33 | 2017-07-14 | 2022-04-27 |
| Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML ADI-PEG 20, Cytarabine - Acute Myeloid Leukemia | Phase 1 | Terminated | Polaris Group | 23 | 2017-01-20 | 2020-03-05 |
| 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 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer ADI-PEG 20 - Advanced Pancreatic Cancer | Phase 1 | Completed | Polaris Group | 21 | 2014-11-17 | 2020-10-01 |
| Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer ADI-PEG 20 - Hepatocellular Carcinoma | Phase 1 | Completed | Polaris Group | 8 | 2014-11-01 | 2016-03-04 |
| 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 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin ADI-PEG 20 - Pleural Mesothelioma Malignant Advanced, Peritoneal Mesothelioma Malignant Advanced | Phase 1 | Terminated | Polaris Group | 85 | 2014-04-23 | 2020-09-25 |
| Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer ADI-PEG 20 - HER2 Negative Metastatic Breast Cancer | Phase 1 | Completed | Polaris Group | 15 | 2014-04-01 | 2016-04-14 |
| 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 |
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Carcinoma, Hepatocellular (5) · Leukemia, Myeloid, Acute (3) · Carcinoma, Non-Small-Cell Lung (2) · Glioblastoma (2) · Sarcoma (2) · Small Cell Lung Carcinoma (2) · Uveal Melanoma (2) · Carcinoma (1) · Colorectal Neoplasms (1) · Glioma (1) · Ichthyosis, X-Linked (1) · Leiomyosarcoma (1) · Liver Neoplasms (1) · Lymphoma, Non-Hodgkin (1) · Melanoma (1)
ADI PEG20 (25) · Polyethylene Glycols (6) · Carboplatin (2) · Pemetrexed (2) · Temozolomide (2) · AZD1390 (1) · Azacitidine (1) · Cisplatin (1) · Cytarabine (1) · Dianhydrogalactitol (1) · Docetaxel (1) · GDC-0084 (1) · Gemcitabine (1) · Ifosfamide (1) · Lomustine (1)
United States (17) · Taiwan (14) · United Kingdom (5) · Italy (3) · South Korea (3) · Australia (2) · Canada (2) · China (2) · Germany (2) · Belgium (1) · France (1) · Switzerland (1) · Vietnam (1)
John S Bomalaski (3) · John S Bomalaski, MD (2) · Siqing Fu, MD (2) · Christine Auberle, M.D. (1) · Cynthia Herzog, MD (1) · Ghassan Abou-Alfa, MD (1) · James Harding, MD (1) · John S Bomalaski, M.D. (1) · Kuo-Chen Wei, M.D. (1) · Lee M Krug, MD (1) · Maeve Lowery, MD (1) · Mia Weiss, M.D. (1) · Pei-Jer Chen, MD, PhD (1) · Peter Szlosarek (1) · Peter Szlosarek, MD, PhD (1)
PMID 28900115, PMID 30796035, PMID 33358660, PMID 33787078, PMID 34382365, PMID 34589965, PMID 35466524, PMID 38358753, PMID 38773224, PMID 41980234