27 Participants Needed

FOLFOXIRI + Panitumumab for Colorectal Cancer

Recruiting at 7 trial locations
EF
RL
SW
NJ
RA
AS
LB
JB
Overseen ByJoaquina Baranda, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase II, open-label, non-randomized study in subjects with histologically confirmed diagnosis of left-sided RAS WT advanced adenocarcinoma of the colon or rectum who have not received prior systemic therapy for metastatic disease.

Who Is on the Research Team?

HH

Howard Hochster, MD

Principal Investigator

Lead Site PI

Are You a Good Fit for This Trial?

Adults with left-sided RAS wild-type advanced colorectal cancer who haven't had systemic therapy for metastatic disease can join. They must have measurable disease, be in good physical condition (ECOG 0-1), and use effective contraception. Exclusions include pregnancy, breastfeeding, certain past cancers or conditions like lung disease, bleeding disorders, severe allergies to monoclonal antibodies, uncontrolled infections or cardiovascular issues.

Inclusion Criteria

Subjects must have signed an approved informed consent
Calcium β‰₯ lower limit of normal
Bilirubin ≀ 1.5 x upper limit of normal
See 17 more

Exclusion Criteria

My blood clotting tests are normal and I've been on a stable dose of blood thinners for at least two weeks.
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
I have only had skin cancer, cervical pre-cancer, or any cancer that hasn't come back in 3 years.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FOLFOXIRI and panitumumab as first-line therapy for metastatic left-sided, RAS WT CRC

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Oxaliplatin
  • Panitumumab
Trial Overview The trial is testing the effectiveness of FOLFOXIRI combined with Panitumumab in treating metastatic colorectal cancer on the left side that hasn't spread elsewhere. It's an open-label phase II study where all participants receive the treatment without being randomly assigned to different groups.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

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Approved in European Union as Eloxatin for:
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Approved in United States as Eloxatin for:
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Approved in Canada as Eloxatin for:
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Approved in Japan as Eloxatin for:
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Approved in Switzerland as Eloxatin for:
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Approved in China as Ai Heng for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Criterium, Inc.

Lead Sponsor

Trials
18
Recruited
730+

Amgen

Industry Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

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