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5-fluorouracil

Phase 1

Stomach Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Dec 19, 2011

Target and mechanism

Molecular targetTYMS
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL185

Also known as 5-Fluorouracil (5-FU)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

5-fluorouracil · 1 trial · 1 indication

Phase 1 1
NCT00555672Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric CancerStomach Neoplasms
COMPLETED34 Analytics
PHASE1COMPLETED
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Stomach NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Cycle 1 (Baseline to Day 21)

The incidence of DLTs assessed during the first cycle (21 days).

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
5-fluorouracilDRUG5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatinDRUGCisplatin is given 80 mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malateDRUGsunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * confirmed diagnosis of stomach cancer * advanced stomach cancer stage IV * adequate blood chemistry, blood counts and kidney function * willing to participate to study requirements and to sign an informed consent document Exclusion Criteria: * prior chemotherapy for stomach ...

Countries:Spain
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Frequently asked questions about 5-fluorouracil

What is 5 fluorouracil used for?

5 fluorouracil, also known as 5-Fluorouracil (5-FU), is an oncology small molecule being studied for metastatic colorectal cancer and stomach neoplasms. It is part of combination chemotherapy regimens, such as FOLFIRI, in clinical trials for these advanced cancers.

What does 5 fluorouracil target?

5 fluorouracil is a small molecule antimetabolite that inhibits thymidylate synthase, disrupting DNA synthesis in rapidly dividing cancer cells. It is used in combination regimens for metastatic colorectal cancer and stomach neoplasms.

Who makes 5 fluorouracil?

5 fluorouracil is being developed by Pfizer, Inc. (NYSE: PFE). The company sponsors clinical trials evaluating the drug in combination with other agents for metastatic colorectal cancer and stomach neoplasms.

What phase is 5 fluorouracil in?

5 fluorouracil is in Phase 3 clinical development for metastatic colorectal cancer. It is also being studied in a Phase 1 trial for stomach neoplasms. The drug is investigational and not yet approved for these indications.

What clinical trials is 5 fluorouracil in?

5 fluorouracil is being studied in NCT00457691, a completed Phase 3 trial of FOLFIRI chemotherapy with or without sunitinib in 768 patients with metastatic colorectal cancer, and NCT00555672, a completed Phase 1 trial of sunitinib with cisplatin and 5-fluorouracil in 34 patients with advanced gastric cancer.

Is 5 fluorouracil the same as 5-Fluorouracil (5-FU)?

Yes, 5 fluorouracil is the same as 5-Fluorouracil (5-FU). It is also referred to as 5-Fluorouracil. These names are used interchangeably in clinical research and medical literature.