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5 fluorouracil

Phase 3

Metastatic Colorectal Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 30, 2015

Target and mechanism

Molecular targetTYMS
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL185

Also known as 5-Fluorouracil (5-FU), 5-Fluorouracil

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment768

FDA Designations

No designations recorded

Clinical trial landscape

5 fluorouracil · 1 trial · 1 indication

Phase 3 1
NCT00457691Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED768 Analytics
PHASE3COMPLETED
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS)
First dose of study treatment up to 30 months

PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.

Secondary Endpoints

Overall Survival (OS)
Baseline up to 30 months
Number of Participants With Overall Confirmed Objective Response
Day 28 of Cycle 1 up to 30 months
Duration of Response (DR)
Day 28 of Cycle 1 up to 30 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
5 fluorouracilDRUG400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
irinotecanDRUG180mg/m2 iv day 1 every 14 days
levo- leucovorinDRUG200mg/m2 iv; day 1 every 14 days
sunitinibDRUG37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
placeboDRUG37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: * Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease. * Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated. * Adequate organ function defined by blood test. Exclusion ...

Countries:ArgentinaAustraliaAustriaBelgiumBosnia and HerzegovinaBrazilBulgariaCanadaChileColombiaCyprusCzechiaGermanyHong KongHungaryIndiaIrelandMexicoNorwayPolandPortugalRomaniaRussiaSerbiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanThailandUkraineUnited Kingdom
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Metastatic Colorectal Cancer")

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.