Fluorouracil

Generic Name: Fluorouracil

Brand Names: Actikerall, Carac, Efudex, Fluoroplex, Tolak

Drug Type: Small Molecule

Chemical Formula: C_₄H_₃FN_₂O_₂

CAS Number: 51-21-8

Unique Ingredient Identifier: U3P01618RT

Background: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid.

Indication: For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

Associated Conditions: Actinic Keratosis (AK), Breast Cancer, Colon Cancer, Gastric Cancer, Pancreatic Cancer, Rectal Cancer, Superficial Basal Cell Carcinoma, Verruca (Warts), Hyperkeratotic actinic keratosis

Clinical Trials

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Drug: ONO-4578
Drug: ONO-4538
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Fluorouracil
Drug: Calcium Levofolinate Hydrateb
Drug: Bevacizumab

First Posted Date: 2024-08-09

Last Posted Date: 2024-08-09

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 40

Registration Number: NCT06547385

Locations: 🇯🇵
Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan
🇯🇵
Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Osaka, Japan
🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

and more 6 locations

Clinical Study of Second-line Treatment in Advanced Colorectal Cancer with Chemotherapy with Bevacizumab or Cetuximab

Phase 2

Recruiting

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: irinotecan liposome (II)
Drug: fluorouracil
Drug: bevacizumab
Drug: cetuximab

First Posted Date: 2024-08-06

Last Posted Date: 2025-02-10

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 100

Registration Number: NCT06540326

Locations: 🇨🇳
The second affiliated hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Unresectable Colorectal Cancer

Interventions: Drug: ONO-7913
Drug: ONO-4538
Drug: Fluorouracil
Drug: Oxaliplatin
Drug: Levofolinate
Drug: Bevacizumab
Drug: Cetuximab

First Posted Date: 2024-08-06

Last Posted Date: 2024-08-06

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 65

Registration Number: NCT06540261

Locations: 🇯🇵
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
🇯🇵
Kurashiki Central Hospital, Kurashiki, Okayama, Japan
🇯🇵
Saitama Medical University International Medical Center, Hidaka, Saitama, Japan

and more 14 locations

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: ONO-4578
Drug: ONO-4538
Drug: Oxaliplatin
Drug: Gemcitabine
Drug: Levofolinate
Drug: Nab-Paclitaxel
Drug: Irinotecan
Drug: Fluorouracil

First Posted Date: 2024-08-05

Last Posted Date: 2025-02-06

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 46

Registration Number: NCT06538207

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
🇯🇵
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
🇯🇵
Seirei Hamamatsu General Hospital, Hamamatsu-shi, Shizuoka, Japan

and more 6 locations

An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: ONO-7913
Drug: ONO-4538
Drug: Oxaliplatin
Drug: Levofolinate
Drug: Irinotecan
Drug: Fluorouracil

First Posted Date: 2024-08-01

Last Posted Date: 2024-11-14

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 32

Registration Number: NCT06532344

Locations: 🇯🇵
National Cancer Center Hospital, Chuo Ku, Japan
🇯🇵
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

and more 6 locations

Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety

Phase 2

Recruiting

Conditions: Pancreatic Cancer Metastatic to Liver

Interventions: Drug: Irinotecan liposome
Drug: Adebrelimab
Drug: Oxaliplatin
Drug: Fluorouracil
Drug: Calcium folinate

First Posted Date: 2024-07-31

Last Posted Date: 2024-07-31

Lead Sponsor: Jiang Long

Target Recruit Count: 40

Registration Number: NCT06531278

Locations: 🇨🇳
Shanghai General Hospital, Shanghai, Shanghai, China

A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo

Phase 3

Not yet recruiting

Conditions: Nodular Prurigo

Interventions: Drug: Triamcinolone Acetonide
Drug: 5-fluorouracil Injection

First Posted Date: 2024-07-29

Last Posted Date: 2024-07-29

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 60

Registration Number: NCT06524323

Locations: 🇨🇳
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer (DDRiver 511)

Phase 1

Suspended

Conditions: Advanced Solid Tumor

Interventions: Drug: M9466
Drug: Irinotecan
Drug: Folinic acid
Drug: Fluorouracil (5-FU)
Drug: Bevacizumab

First Posted Date: 2024-07-19

Last Posted Date: 2025-02-26

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 54

Registration Number: NCT06509906

Locations: 🇺🇸
Sarah Cannon Research Institute at Health One, Denver, Colorado, United States
🇺🇸
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center, Pennington, New Jersey, United States
🇺🇸
Vanderbilt University - 150912667, Nashville, Tennessee, United States

and more 9 locations