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FOLFOXIRI+ Panitumumab

Phase 2

Metastatic Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 15, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

FOLFOXIRI+ Panitumumab · 1 trial · 1 indication

Phase 2 1
NCT01328171FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)Metastatic Colorectal Cancer
COMPLETED93 Analytics
PHASE2COMPLETED
FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

overall response rate
up to about 6 month

RECIST

Secondary Endpoints

overall response rate in each cohort
up to about 6 month
secondary resection rate with curative intent for patients cohort I
up to about 6 month
pathological response in liver surgery specimen
up to about 6 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A (FOLFOXIRI + Panitumumab)EXPERIMENTALFOLFOXIRI + Panitumumab
B (FOLFOXIRI)ACTIVE_COMPARATORFOLFOXIRI

Interventions

NameTypeDescription
FOLFOXIRI + PanitumumabDRUGirinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3000 mg/m² cont. inf. + panitumumab, iv, 6 mg/kg BW all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
FOLFOXIRIDRUGirinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease * Cohort II: Chance of secondary resection with curative intent define...

Countries:Germany
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Competitive Landscape -Colorectal Cancer 257 trials (matched to "Metastatic Colorectal Cancer")