Eflornithine

DRUG19 trials

Sponsors

University of Michigan Rogel Cancer Center, National Cancer Institute (NCI), University of Wisconsin, Madison, M.D. Anderson Cancer Center, Thomas E. Ahlering

Conditions

Adenomatous PolypAnaplastic AstrocytomaAnaplastic OligodendrogliomaAstrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4Bladder CancerCervical CancerColorectal Cancer

Early Phase 1

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

RecruitingNCT05717153

Mayo ClinicDiffuse Glioma, Malignant Glioma

Start: 2023-10-01End: 2027-09-15Target: 18Updated: 2025-11-04

Phase 1

Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas

Not yet recruitingNCT07468136

Mayo ClinicAnaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4 +3

Start: 2026-04-24End: 2030-10-25Target: 33Updated: 2026-03-12

Phase 2

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

CompletedNCT00033371

National Cancer Institute (NCI)Colorectal Cancer, Familial Adenomatous Polyposis

Start: 2001-12-13End: 2009-03-24Updated: 2020-09-29

Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

CompletedNCT00006101

Thomas E. AhleringProstate Cancer

Start: 1998-10-31End: 2012-12-31Updated: 2018-05-14

Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

CompletedNCT00021294

University of ArizonaNon-melanomatous Skin Cancer, Precancerous/Nonmalignant Condition

Start: 2001-05-31End: 2002-06-30Updated: 2018-09-11

Eflornithine to Prevent Cancer in Patients With Barrett's Esophagus

CompletedNCT00003076

University of Michigan Rogel Cancer CenterEsophageal Cancer

Start: 1995-10-31End: 2005-10-31Target: 152Updated: 2012-12-19

Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

CompletedNCT00006079

M.D. Anderson Cancer CenterCervical Cancer, Precancerous Condition

Start: 1998-06-19End: 2004-04-27Updated: 2018-10-25

Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy

CompletedNCT00086736

University of Alabama at BirminghamProstate Cancer

Start: 2001-11-30End: 2003-11-30Updated: 2013-11-19

Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

CompletedNCT00983580

National Cancer Institute (NCI)Adenomatous Polyp

Start: 2009-08-20End: 2019-08-13Updated: 2019-09-04

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

CompletedNCT01685827

Drugs for Neglected DiseasesHuman African Trypanosomiasis (HAT), Sleeping Sickness

Start: 2012-10-31End: 2017-04-26Updated: 2018-02-20

Chemoprevention of Gastric Carcinogenesis

CompletedNCT02794428

Vanderbilt-Ingram Cancer CenterGastric Cancer, Gastric Intestinal Metaplasia

Start: 2016-09-19End: 2024-07-01Updated: 2024-10-16

Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

RecruitingNCT04301843

Giselle ShollerNeuroblastoma

Start: 2020-09-25End: 2033-10-01Target: 131Updated: 2026-02-03

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Not yet recruitingNCT07321912

Milton S. Hershey Medical CenterEwing Sarcoma, Ewing Sarcoma Metastatic, Osteosarcoma

Start: 2026-04-01End: 2036-04-01Target: 406Updated: 2026-01-08

Phase 3

Eflornithine in Treating Patients With Bladder Cancer

CompletedNCT00003814

National Cancer Institute (NCI)Bladder Cancer

Start: 1999-02-28End: 2007-05-31Target: 450Updated: 2013-12-18

Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer

CompletedNCT00005884

University of Wisconsin, MadisonNon-melanomatous Skin Cancer

Updated: 2019-12-13

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

CompletedNCT00118365

National Cancer Institute (NCI)Precancerous Condition

Start: 1998-07-31End: 2008-08-31Updated: 2015-01-22

Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

CompletedNCT00146627

Drugs for Neglected DiseasesTrypanosomiasis, African

End: 2008-06-30Target: 280Updated: 2016-09-29

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

CompletedNCT01483144

Cancer Prevention Pharmaceuticals, Inc.Familial Adenomatous Polyposis

Start: 2013-10-31End: 2019-03-31Updated: 2021-06-08

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Orbus Therapeutics, Inc.Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma

Start: 2016-07-31End: 2023-06-30Updated: 2022-01-21

Related Papers

Safety and Efficacy of Eflornithine in Patients with Gastric Precancerous Lesions: A Double-blinded, Randomized Clinical Trial.

2026-03-09

STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma.

2025-12-01

A first-in-human pharmacodynamic evaluation of dual polyamine depletion for patients with high-grade gliomas.

Journal of Clinical Oncology2023-06-011 citations

Abstract A016: Successful design and execution of two gastric cancer chemoprevention trials in Central America and Puerto Rico

Cancer Prevention Research2022-12-011 citations

Combination of Sulindac and Eflornithine Delays the Need for Lower Gastrointestinal Surgery in Patients With Familial Adenomatous Polyposis: Post Hoc Analysis of a Randomized Clinical Trial

Diseases of the Colon & Rectum2021-07-1517 citations

Oral fexinidazole for stage 1 or early stage 2 African Trypanosoma brucei gambiense trypanosomiasis: a prospective, multicentre, open-label, cohort study.

2021-07-0136 citations

Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis

New England Journal of Medicine2020-09-0964 citations

Oral fexinidazole for late-stage African Trypanosoma brucei gambiense trypanosomiasis: a pivotal multicentre, randomised, non-inferiority trial.

2017-11-04169 citations

Abstract CT136: STELLAR: A phase 3, randomized, open-label study to evaluate the efficacy and safety of eflornithine with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that progress/recur after irradiation and adjuvant temozolomide chemotherapy

Cancer Research2017-07-01

STELLAR: A phase 3, randomized, open-label study of eflornithine with lomustine vs lomustine for patients with first recurrence of anaplastic astrocytoma after RT and adjuvant temozolomide.

Journal of Clinical Oncology2017-05-20

Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial.

2016-08-0232 citations

Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial.

2009-06-24337 citations