Recent Updates
Recently added Catalysts

FOLFOXIRI+ Panitumumab

Phase 4FDA approved

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

FOLFOXIRI+ Panitumumab development status

FDA approval on record Approved
Highest phase Phase 4 (NCT03994731)
Phase scored for AMGNPhase 2
Registered trials 539 across 178 sponsors since Apr 2002

FOLFOXIRI+ Panitumumab target and mechanism

ModalitySmall molecule

Also known as Vectibix (Panitumumab), folic acid, 5-FU, oxaliplatin, irinotecan

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

FOLFOXIRI+ Panitumumab clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Colorectal Cancer 363 trials (matched to "Metastatic Colorectal Cancer")

Unlock Competitive Intelligence

Frequently asked questions about FOLFOXIRI+ Panitumumab

What is FOLFOXIRI+ Panitumumab used for?

FOLFOXIRI+ Panitumumab is studied for metastatic colorectal cancer. It combines the FOLFOXIRI chemotherapy regimen with panitumumab, an EGFR-targeted antibody. The combination has been evaluated in a biomarker-selected patient population in a Phase 2 trial.

Who is developing FOLFOXIRI+ Panitumumab?

Amgen Inc. (ticker: AMGN) develops panitumumab, the targeted agent in the FOLFOXIRI+ Panitumumab combination. Amgen is the company associated with this drug asset.

What phase is FOLFOXIRI+ Panitumumab in?

FOLFOXIRI+ Panitumumab is in Phase 2 development. The single registered trial, NCT01328171, has completed. The drug is investigational and is not approved for use.

What clinical trials is FOLFOXIRI+ Panitumumab in?

FOLFOXIRI+ Panitumumab has been studied in one clinical trial: NCT01328171, titled FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI). This completed Phase 2 trial enrolled 93 patients in Germany and was active-controlled and randomized.