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Panitumumab

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Exelixis, Inc.|Last Updated: Feb 12, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

Panitumumab · 1 trial · 1 indication

Phase 1 1
NCT02008383Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal CancerColorectal Cancer
COMPLETED29 Analytics
PHASE1COMPLETED
Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended phase II dose (RPTD) for the combination of cabozantinib and panitumumab
RPTD for the study will be determined at the completion of Phase I dose escalation cohort; estimated as 1 year
Objective response rate (ORR) of cabozantinib monotherapy in patients with prospectively identified MET amplified metastatic colorectal cancer
Approximately every 8 weeks and/or restaging

Secondary Endpoints

Non-dose limiting toxicities of cabozantinib and panitumumab.
Continuous, every 4 weeks minimum until end of study estimated at 4 years
Response rate of cabozantinib and panitumumab
approximately every 8 weeks and/or restaging
Progression free survival associated with the cabozantinib and panitumumab regimen
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cabozantinib and PanitumumabEXPERIMENTAL60 mg Cabozantinib PO daily and 6 mg/kg Panitumumab IV every 2 weeks.
CabozantinibEXPERIMENTAL60 mg Cabozantinib PO daily.

Interventions

NameTypeDescription
PanitumumabBIOLOGICALThe FDA approved dose for panitumumab is 6mg/kg IV, every two weeks. This is the dose and schedule that will be used in this study.
CabozantinibDRUGThere will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. Cabozantinib will start at a dose of 60 mg daily with reductions to 40 and 20 mg daily possible in the dose finding cohort. The combination expansion cohort dose will determined by the dose finding cohort. The Monotherapy MET Amplified cohort will recieve 60 mg Cabozantinib daily.
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Eligibility Criteria

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

MET Amplification Screening Test Inclusion Criteria: 1. Histologically and/or cytologically confirmed and radiographically measurable KRAS wild-type adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable. Subjects must have been treated with a fluoropyrimidine (e.g., 5-fluoro...

Countries:United States
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Frequently asked questions about Panitumumab

What is Panitumumab used for in Colorectal Cancer?

Panitumumab is a monoclonal antibody being studied for the treatment of colorectal cancer. It is currently in Phase 1 clinical development as an investigational therapy. In a completed Phase 1 trial, it was evaluated in combination with cabozantinib for patients with KRAS wild-type metastatic colorectal cancer.

What does Panitumumab target?

Panitumumab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR). By binding to EGFR, it is designed to interfere with cancer cell growth and survival pathways. This mechanism is relevant in colorectal cancer, particularly in tumors that are KRAS wild-type, where EGFR signaling plays a role in disease progression.

Who makes Panitumumab?

Panitumumab is being developed by Exelixis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EXEL. The company is conducting clinical research to evaluate the drug's safety and efficacy in colorectal cancer, with the most recent trial being a Phase 1 study.

What phase is Panitumumab in?

Panitumumab is in Phase 1 clinical development for colorectal cancer. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial, which has been completed, enrolled 29 participants and was designed to assess the combination of panitumumab with cabozantinib in metastatic colorectal cancer.

What clinical trials is Panitumumab in?

Panitumumab has been studied in one clinical trial, identified as NCT02008383, titled 'Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer.' This Phase 1 trial was completed and enrolled 29 participants in the United States. The study was controlled but not randomized or double-blinded, and it included biomarker-selected patients.

Is Panitumumab the same as Vectibix?

Panitumumab is the same drug as Vectibix, which is a brand name for panitumumab. In clinical trials, it is referred to by its generic name, panitumumab. The drug is being investigated for use in colorectal cancer, particularly in patients with KRAS wild-type tumors, as part of a combination therapy approach.