ADI-PEG 20

DRUG19 trials

Sponsors

FDA Office of Orphan Products Development, Barts & The London NHS Trust, Polaris Group, Global Coalition for Adaptive Research, Washington University School of Medicine

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia, AdultAdvanced Pancreatic CancerArgininosuccinate Synthetase DeficientCarcinoma, HepatocellularCutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid TumorsGlioblastomaGlioblastoma Multiforme (GBM)

Phase 1

Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

CompletedNCT01497925

Polaris GroupProstate Cancer, Solid Tumors

Start: 2011-09-06End: 2018-08-31Updated: 2018-09-13

Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient

CompletedNCT01528384

Polaris GroupArgininosuccinate Synthetase Deficient

Start: 2011-12-31End: 2014-03-31Updated: 2014-04-09

Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

CompletedNCT01665183

Polaris GroupCutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors

Start: 2012-09-30End: 2016-02-29Updated: 2016-02-25

Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

CompletedNCT01948843

Polaris GroupHER2 Negative Metastatic Breast Cancer

Start: 2014-04-30End: 2016-04-30Updated: 2016-04-14

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

TerminatedNCT02029690

Polaris GroupGlioma, Hepatocellular Carcinoma, Non-squamous Non-small Cell Lung Carcinoma +4

Start: 2014-04-23End: 2020-06-30Updated: 2020-09-25

Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer

CompletedNCT02101580

Polaris GroupAdvanced Pancreatic Cancer

Start: 2014-11-17End: 2017-10-06Updated: 2020-10-01

Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

CompletedNCT02101593

Polaris GroupHepatocellular Carcinoma

Start: 2014-11-30End: 2016-03-31Updated: 2016-03-04

Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML

TerminatedNCT02875093

Polaris GroupAcute Myeloid Leukemia

Start: 2017-01-20End: 2019-07-10Updated: 2020-03-05

Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

Active, not recruitingNCT05001828

Polaris GroupAcute Myeloid Leukemia, Adult

Start: 2022-04-05End: 2026-12-01Updated: 2026-01-21

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers

Active, not recruitingNCT05616624

Washington University School of MedicineNon-small Cell Lung Cancer, Non Small Cell Lung Cancer, Small-cell Lung Cancer +1

Start: 2023-04-05End: 2033-12-31Updated: 2026-02-04

A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

WithdrawnNCT06006286

M.D. Anderson Cancer CenterMetastatic Hepatocellular Carcinoma

Start: 2023-08-08End: 2023-11-10Updated: 2024-08-26

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

RecruitingNCT06085729

M.D. Anderson Cancer CenterProstate Cancer

Start: 2024-02-29End: 2027-12-31Target: 30Updated: 2026-04-02

Phase 2

Testing of ADI-PEG in Hepatocellular Carcinoma

CompletedNCT00056992

FDA Office of Orphan Products DevelopmentCarcinoma, Hepatocellular

Start: 2002-09-30End: 2003-10-31Target: 34Updated: 2015-03-25

A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma

Barts & The London NHS TrustMalignant Pleural Mesothelioma

Start: 2011-01-31End: 2015-03-31Updated: 2014-11-20

PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

CompletedNCT01910025

Polaris GroupNon-Hodgkin's Lymphoma

Start: 2013-12-06End: 2017-12-15Updated: 2018-09-18

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

CompletedNCT01910012

Polaris GroupAcute Myeloid Leukemia

Start: 2015-01-06End: 2017-05-05Updated: 2020-10-01

Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

CompletedNCT02006030

Polaris GroupUnresectable Hepatocellular Carcinoma

Start: 2014-10-15End: 2017-11-01Updated: 2018-09-04

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

RecruitingNCT03970447

Global Coalition for Adaptive ResearchGlioblastoma

Start: 2019-07-30End: 2030-06-01Target: 2250Updated: 2026-04-03

ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme

Active, not recruitingNCT04587830

Polaris GroupGlioblastoma Multiforme (GBM)

Start: 2020-09-14End: 2027-05-30Updated: 2025-08-26

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