NCT01910012 is a Phase 2 clinical trial of ADI-PEG 20 in Acute Myeloid Leukemia, sponsored by Polaris Group.

Who is sponsoring NCT01910012?

NCT01910012 is sponsored by Polaris Group.

What drugs are being tested in NCT01910012?

Interventions in NCT01910012: ADI-PEG 20.

What condition does NCT01910012 study?

NCT01910012 studies Acute Myeloid Leukemia.

Is NCT01910012 still recruiting?

NCT01910012 is currently completed. Last updated 1 October 2020.

Last reviewed 2020-10-01 · How we verify

NCT01910012

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

Completed Phase 2 Last updated 1 October 2020

What this trial tests

Phase 2 trial testing ADI-PEG 20 in Acute Myeloid Leukemia in 43 participants. Completed in 5 May 2017.

Timeline

6 January 2015

Primary endpoint
12 September 2016

5 May 2017

Quick facts

Lead sponsor	Polaris Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	6 January 2015
Primary completion	12 September 2016
Estimated completion	5 May 2017
Sites	6 locations across Taiwan, United States

Drugs / interventions tested

ADI-PEG 20 — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Polaris Group — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Arginine Signaling and Cancer Metabolism.
Chen CL, Hsu SC, Ann DK, Yen Y, et al · · 2021 · cited 179× · PMID 34298755 · DOI 10.3390/cancers13143541
Arginine-Dual roles as an onconutrient and immunonutrient.
Albaugh VL, Pinzon-Guzman C, Barbul A. · · 2017 · cited 98× · PMID 27861915 · DOI 10.1002/jso.24490
Mitochondrial metabolism as a target for acute myeloid leukemia treatment.
Panina SB, Pei J, Kirienko NV. · · 2021 · cited 68× · PMID 33883040 · DOI 10.1186/s40170-021-00253-w
Targeting Metabolic Reprogramming in Acute Myeloid Leukemia.
Castro I, Sampaio-Marques B, Ludovico P. · · 2019 · cited 63× · PMID 31450562 · DOI 10.3390/cells8090967
A Phase II Study of Arginine Deiminase (ADI-PEG20) in Relapsed/Refractory or Poor-Risk Acute Myeloid Leukemia Patients.
Tsai HJ, Jiang SS, Hung WC, Borthakur G, et al · · 2017 · cited 58× · PMID 28900115 · DOI 10.1038/s41598-017-10542-4
The Importance of Cellular Metabolic Pathways in Pathogenesis and Selective Treatments of Hematological Malignancies.
Soltani M, Zhao Y, Xia Z, Ganjalikhani Hakemi M, et al · · 2021 · cited 50× · PMID 34868994 · DOI 10.3389/fonc.2021.767026
Rationale for Targeting Deregulated Metabolic Pathways as a Therapeutic Strategy in Acute Myeloid Leukemia.
Chapuis N, Poulain L, Birsen R, Tamburini J, et al · · 2019 · cited 26× · PMID 31192118 · DOI 10.3389/fonc.2019.00405
Unlocking the Potential of Arginine Deprivation Therapy: Recent Breakthroughs and Promising Future for Cancer Treatment.
Chu YD, Lai MW, Yeh CT. · · 2023 · cited 24× · PMID 37445845 · DOI 10.3390/ijms241310668

Verify or expand the search:

Other trials of ADI-PEG 20

Trials testing the same drug.

NCT06085729 — Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Var · Phase 1, PHASE2 · recruiting
NCT06006286 — A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocel · Phase 1, PHASE2 · withdrawn
NCT05616624 — ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Sm · Phase 1, PHASE2 · active not recruiting
NCT04587830 — ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme · Phase 2 · active not recruiting
NCT02875093 — Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML · Phase 1 · terminated

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Polaris Group trials

Trials by the same sponsor.

NCT05712694 — Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC) · Phase 3 · recruiting
NCT05842512 — Study of ADI-PEG 20 Versus Placebo in Subjects With NASH · Phase 2 · recruiting
NCT04587830 — ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme · Phase 2 · active not recruiting
NCT02709512 — Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin · Phase 2, PHASE3 · completed
NCT03254732 — Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01910012 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Polaris Group
Last refreshed: 1 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01910012.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing