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21Capecitabine+ bevacizumab+ oxaliplatin

Phase 3

Colorectal Cancer | Small molecule | Oncology |Sanofi|Last Updated: Feb 2, 2012

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment750

FDA Designations

No designations recorded

Clinical trial landscape

21Capecitabine+ bevacizumab+ oxaliplatin · 1 trial · 1 indication

Phase 3 1
NCT00208546Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal CancerColorectal Cancer
COMPLETED750 Analytics
PHASE3COMPLETED
Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

progression free survival
study duration
toxicity
study duration

Secondary Endpoints

tumour response (complete response [CR], partial response [PR] or stable disease [SD])
study duration
response duration
study duration
overall survival
study duration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1Capecitabine + bevacizumab + oxaliplatin + cetuximabEXPERIMENTAL -
21Capecitabine + bevacizumab + oxaliplatinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
21Capecitabine + bevacizumab + oxaliplatinDRUG3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1.
1Capecitabine + oxaliplatin + bevacizumab + cetuximabDRUG3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1, Ce 250 mg/m2 i.v. day 1, 8, 15 (day 1 cycle 1: 400 mg/m2).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Histology and Staging Disease * Histologically proven advanced colorectal cancer (CRC); not amenable to curative surgery * Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation. * Unidimensio...

Countries:Netherlands
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Frequently asked questions about 21Capecitabine+ bevacizumab+ oxaliplatin

What is 21Capecitabine+ bevacizumab+ oxaliplatin used for in Colorectal Cancer?

21Capecitabine+ bevacizumab+ oxaliplatin is a combination regimen being studied for the treatment of Colorectal Cancer. It is an investigational combination of capecitabine, bevacizumab, and oxaliplatin, developed by Sanofi. The regimen is currently in Phase 3 clinical development for this indication.

Who makes 21Capecitabine+ bevacizumab+ oxaliplatin?

Sanofi (ticker: SNY) is the developer of 21Capecitabine+ bevacizumab+ oxaliplatin. The company is conducting clinical research on this combination regimen for the treatment of Colorectal Cancer. The regimen is currently in Phase 3 development.

What phase is 21Capecitabine+ bevacizumab+ oxaliplatin in?

21Capecitabine+ bevacizumab+ oxaliplatin is in Phase 3 clinical development for Colorectal Cancer. It is an investigational combination regimen and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with a total enrollment of 750 participants.

What clinical trials is 21Capecitabine+ bevacizumab+ oxaliplatin in?

21Capecitabine+ bevacizumab+ oxaliplatin has one completed Phase 3 trial, NCT00208546, titled 'Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer'. This trial enrolled 750 participants with Colorectal Cancer and was conducted in the Netherlands. The trial was randomized and active-controlled.

Is 21Capecitabine+ bevacizumab+ oxaliplatin the same as capecitabine, bevacizumab, and oxaliplatin?

21Capecitabine+ bevacizumab+ oxaliplatin is a combination regimen that includes capecitabine, bevacizumab, and oxaliplatin. The name indicates the combination of these three drugs. It is being studied as a treatment for Colorectal Cancer and is currently in Phase 3 clinical development by Sanofi.