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Fluoropyrimidine-based Chemotherapy

Phase 3

Colorectal Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Dec 8, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

Fluoropyrimidine-based Chemotherapy · 1 trial · 1 indication

Phase 3 1
NCT01169558A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.Colorectal Cancer
COMPLETED168 Analytics
PHASE3COMPLETED
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Number of Participants With Serious and Specific Adverse Events
Up to approximately 3 years

A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.

Secondary Endpoints

Efficacy: Overall Survival
Up to approximately 3 years
Efficacy: Time to Disease Progression
Up to approximately 3 years
Efficacy: Progression-free Survival
Up to approximately 3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BevacizumabEXPERIMENTALBevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Interventions

NameTypeDescription
BevacizumabDRUG5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.
Fluoropyrimidine-based ChemotherapyDRUGFluoropyrimidine-based chemotherapy administered according to standard of care.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Previously untreated metastatic colon or rectal cancer; * Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment. Exclusion Criteria: * Prior chemotherapy for metastatic colon or rectal cancer; * Planned radiotherapy for underlying disease; * centra...

Countries:Brazil
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Frequently asked questions about Fluoropyrimidine-based Chemotherapy

What is Fluoropyrimidine-based Chemotherapy used for in Colorectal Cancer?

Fluoropyrimidine-based Chemotherapy is used for the treatment of Colorectal Cancer, specifically in combination with bevacizumab (Avastin) for participants with metastatic cancer of the colon or rectum. It is a small molecule modality being studied in the oncology therapeutic area.

Who makes Fluoropyrimidine-based Chemotherapy?

Fluoropyrimidine-based Chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this chemotherapy regimen for colorectal cancer.

What phase is Fluoropyrimidine-based Chemotherapy in?

Fluoropyrimidine-based Chemotherapy is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with colorectal cancer.

What clinical trials is Fluoropyrimidine-based Chemotherapy in?

Fluoropyrimidine-based Chemotherapy is associated with one completed Phase 3 clinical trial, NCT01169558, titled 'A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.' The trial enrolled 168 participants in Brazil and included adults aged 18 years and older.

Is Fluoropyrimidine-based Chemotherapy the same as bevacizumab?

No, Fluoropyrimidine-based Chemotherapy is not the same as bevacizumab. It is a chemotherapy regimen that is studied in combination with bevacizumab (Avastin) for the treatment of metastatic colorectal cancer. The two are distinct drugs used together in the clinical trial.