11 completed, 3 terminated, 2 active not recruiting, 2 recruiting. 13 Phase 1, 13 Phase 2, 1 Phase 3.
Follow ADI-PEG 20: new trials by email Literature Review of ADI-PEG 20 trials Research Report on ADI-PEG 20
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 | 2026-09-15 |
| 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 |
| 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Carcinoma Atezolizumab, Bevacizumab, ADI-PEG 20 - Metastatic Hepatocellular Carcinoma | Phase 1 / Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2023-08-08 | 2024-08-26 | |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of Resectable Liver Cancer Nivolumab, Pegargiminase, Resection - Resectable Hepatocellular Carcinoma | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2022-04-13 | 2023-02-16 | |
| 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 |
| 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 | 2026-10-23 |
| 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 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 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 |
| Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma ADI-PEG 20 - Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors | Phase 1 | Completed | Polaris Group | 8 | 2012-09-01 | 2016-02-25 |
| Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient ADI-PEG 20 - Argininosuccinate Synthetase Deficient | Phase 1 | Completed | Polaris Group | 8 | 2011-12-01 | 2014-04-09 |
| Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer ADI-PEG 20 - Solid Tumors, Prostate Cancer | Phase 1 | Completed | Polaris Group | 43 | 2011-09-06 | 2018-09-13 |
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Carcinoma, Hepatocellular (4) · Glioblastoma (3) · Leukemia, Myeloid, Acute (3) · Glioma (2) · Prostatic Neoplasms (2) · Uveal Melanoma (2) · Carcinoma (1) · Carcinoma, Non-Small-Cell Lung (1) · Liver Neoplasms (1) · Lymphoma, Non-Hodgkin (1) · Melanoma (1) · Mesothelioma, Malignant (1) · Ovarian Neoplasms (1) · Recurrence (1) · Sarcoma (1)
Polaris Group (13) · M.D. Anderson Cancer Center (3) · Washington University School of Medicine (2) · Barts & The London NHS Trust (1) · FDA Office of Orphan Products Development (1) · Global Coalition for Adaptive Research (1) · Sabine Mueller, MD, PhD (1)
United States (17) · Taiwan (6) · United Kingdom (2) · Australia (1) · Canada (1) · France (1) · Germany (1) · South Korea (1) · Switzerland (1)
Siqing Fu, MD (2) · Ana Aparicio, MD (1) · Christine Auberle, M.D. (1) · Cynthia Herzog, MD (1) · Ghassan Abou-Alfa, MD (1) · John S Bomalaski, MD (1) · Kuo-Chen Wei, M.D. (1) · Maeve Lowery, MD (1) · Mia Weiss, M.D. (1) · Pei-Jer Chen, MD, PhD (1) · Peter Szlosarek (1) · Peter Szlosarek, MD, PhD (1) · Sabine Mueller, MD, PhD (1) · Sunyoung Lee (1) · Tim Cloughesy, MD (1)
PMID 27584578, PMID 28900115, PMID 30796035, PMID 33787078, PMID 34382365, PMID 35466524, PMID 38773224, PMID 41980234
R01CA227115 (1)