FOLFOXIRI + Panitumumab for Colorectal Cancer

Recruiting at 7 trial locations

Overseen By Joaquina Baranda, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Criterium, Inc.

Must not be taking: Antivirals

Disqualifiers: Pregnancy, Cardiovascular disease, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

Trial Summary

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.

Research Team

Howard Hochster, MD

Principal Investigator

Lead Site PI

Eligibility Criteria

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 ≥ lower limit of normal

Bilirubin ≤ 1.5 x upper limit of normal

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.

Treatment Details

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.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

This is an open label study single arm

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

Approved in European Union as Eloxatin for:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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