5-Fluorouracil: clinical trials recruiting now
15
Recruiting trials
15
Conditions studied
37
US states with sites
32
Countries
FDA drug label
- FDA-approved
- Yes. 5-Fluorouracil appears in the FDA drug-label database. Marketed as FLUOROURACIL.
- Drug class
- Nucleoside Metabolic Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Nucleic Acid Synthesis Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for 5-Fluorouracil carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Fluorouracil injection is indicated for the treatment of patients with: Fluorouracil injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum . 1.2 Adenocarcinoma of the Breast . 1.3 Gastric Adenocarcinoma . 1.4 Pancreatic Adenocarcinoma .
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. — Taro Pharmaceuticals U.S.A., Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-11-21 |
| Presence of Particulate Matter; glass particulates — Fresenius Kabi USA, LLC | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2019-06-28 |
Phase breakdown
Phase 1 5
Phase 2 6
Phase 3 4
Not applicable 1
Conditions being studied
Recruiting trials involving 5-Fluorouracil
- A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
- A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
- A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
- A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
- AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
- Adaptive Radiation in Anal Cancer
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
- Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
- MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
- Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
- Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
- Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
- Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Common questions
Is 5-Fluorouracil FDA-approved?
Yes, marketed as FLUOROURACIL. Its FDA label carries a boxed warning.
How many recruiting trials involve 5-Fluorouracil?
15 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.