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XELOX

Phase 3

Colorectal Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 18, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

XELOX · 1 trial · 1 indication

Phase 3 1
NCT00349336A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.Colorectal Cancer
COMPLETED64 Analytics
PHASE3COMPLETED
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Weekly Steady-state Exposure of Bevacizumab
Up to 48 weeks

Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.

Secondary Endpoints

Time Zero to Last Measurable Plasma Concentration of Bevacizumab
Up to 48 weeks
Steady-state Exposure of Bevacizumab From Time Zero to Tau
Up to 48 weeks
Maximum Serum Concentration of Bevacizumab at Steady State
Up to 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
bevacizumab [Avastin]DRUG7.5mg/kg iv on day 1 of each 3 week cycle
XELOXDRUGAs prescribed
FOLFOX-4DRUGAs prescribed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * adult patients, \>=18 years of age; * adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease; * \>=1 target lesion. Exclusion Criteria: * patients who have previously received systemic treatment for advanced or metastatic disease; * patients who h...

Countries:AustraliaCanadaNew Zealand
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Frequently asked questions about XELOX

What is XELOX used for in colorectal cancer?

XELOX is a chemotherapy regimen used for colorectal cancer, specifically studied in metastatic colorectal cancer. It is a combination treatment evaluated in a Phase 3 clinical trial. The drug is developed by Roche Holding AG and is in the oncology therapeutic area.

What does XELOX target?

XELOX is a small molecule modality. The specific molecular target is not provided in the available information. It is used in combination with Avastin (bevacizumab) in the treatment of metastatic colorectal cancer, as studied in clinical trials.

Who makes XELOX?

XELOX is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical development of this chemotherapy regimen for colorectal cancer.

What phase is XELOX in?

XELOX is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT00349336, which evaluated the drug in combination with Avastin (bevacizumab) in patients with metastatic colorectal cancer. The trial is completed, and XELOX remains an investigational regimen.

What clinical trials is XELOX in?

XELOX has one completed Phase 3 clinical trial, NCT00349336, titled "A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer." The trial enrolled 64 participants and was conducted in Australia, Canada, and New Zealand.

Is XELOX the same as capecitabine and oxaliplatin?

XELOX is a combination chemotherapy regimen that includes capecitabine and oxaliplatin. The available information does not provide alternative names for XELOX, but it is commonly known as a regimen combining these two agents for colorectal cancer treatment.