NCT02101580 is a Phase 1 clinical trial of ADI-PEG 20 in Advanced Pancreatic Cancer, sponsored by Polaris Group.

Who is sponsoring NCT02101580?

NCT02101580 is sponsored by Polaris Group.

What drugs are being tested in NCT02101580?

Interventions in NCT02101580: ADI-PEG 20.

What condition does NCT02101580 study?

NCT02101580 studies Advanced Pancreatic Cancer.

Is NCT02101580 still recruiting?

NCT02101580 is currently completed. Last updated 1 October 2020.

Last reviewed 2020-10-01 · How we verify

NCT02101580

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

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

Completed Phase 1 Last updated 1 October 2020

What this trial tests

Phase 1 trial testing ADI-PEG 20 in Advanced Pancreatic Cancer in 21 participants. Completed in 6 October 2017.

Timeline

17 November 2014

Primary endpoint
5 May 2017

6 October 2017

Quick facts

Lead sponsor	Polaris Group
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	17 November 2014
Primary completion	5 May 2017
Estimated completion	6 October 2017
Sites	1 location across United States

Drugs / interventions tested

ADI-PEG 20 — full drug profile →

Conditions studied

Advanced Pancreatic Cancer — all drugs for Advanced Pancreatic Cancer →

Sponsor

Polaris Group — full company profile →

Who can join

18 and older, any sex, with Advanced Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma.

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
Phase 1 Dose-Escalation Study of Pegylated Arginine Deiminase, Cisplatin, and Pemetrexed in Patients With Argininosuccinate Synthetase 1-Deficient Thoracic Cancers.
Beddowes E, Spicer J, Chan PY, Khadeir R, et al · · 2017 · cited 92× · PMID 28388291 · DOI 10.1200/jco.2016.71.3230
Nano albumin bound-paclitaxel in pancreatic cancer: Current evidences and future directions.
Giordano G, Pancione M, Olivieri N, Parcesepe P, et al · · 2017 · cited 67× · PMID 28932079 · DOI 10.3748/wjg.v23.i32.5875
Arginine Starvation and Docetaxel Induce c-Myc-Driven hENT1 Surface Expression to Overcome Gemcitabine Resistance in ASS1-Negative Tumors.
Prudner BC, Rathore R, Robinson AM, Godec A, et al · · 2019 · cited 53× · PMID 31113844 · DOI 10.1158/1078-0432.ccr-19-0206
Reprogramming of Amino Acid Metabolism in Pancreatic Cancer: Recent Advances and Therapeutic Strategies.
Xu R, Yang J, Ren B, Wang H, et al · · 2020 · cited 52× · PMID 33117704 · DOI 10.3389/fonc.2020.572722
Metastatic pancreatic cancer: Is there a light at the end of the tunnel?
Vaccaro V, Sperduti I, Vari S, Bria E, et al · · 2015 · cited 49× · PMID 25944992 · DOI 10.3748/wjg.v21.i16.4788
Emerging mechanisms and promising approaches in pancreatic cancer metabolism.
Wu H, Fu M, Wu M, Cao Z, et al · · 2024 · cited 48× · PMID 39090116 · DOI 10.1038/s41419-024-06930-0
Targeting cancer metabolic pathways for improving chemotherapy and immunotherapy.
Luo Z, Eichinger KM, Zhang A, Li S. · · 2023 · cited 40× · PMID 37739209 · DOI 10.1016/j.canlet.2023.216396

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 Advanced Pancreatic Cancer

Currently open trials in the same condition.

NCT07416240 — Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer. · EARLY_PHASE1 · recruiting
NCT07006077 — Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer · Phase 2 · recruiting
NCT06111274 — A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer · Phase 2 · recruiting
NCT06078787 — Olaparib in PALB2 Advanced Pancreatic Cancer · Phase 2 · recruiting
NCT05916261 — Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer · EARLY_PHASE1 · 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 NCT02101580 (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/NCT02101580.

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