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Monoclonal Antibodies

Panitumumab for Colorectal Cancer

Phase 2

Waitlist Available

Led By John H Strickler

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support (obtained =< 7 days prior to randomization)

Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to receipt of anti EGFR therapy

Must not have

Serious, non-healing wound, ulcer, or bone fracture

Any hemorrhage or bleeding event >= NCI CTCAE v5.0 grade 3, =< 4 weeks prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing panitumumab to the standard of care for treating patients with colorectal cancer that has spread and is negative for RAS wild-type.

Who is the study for?

Adults with RAS wild-type colorectal cancer that has spread and/or can't be surgically removed, who have tried anti-EGFR therapy for at least 3 months. They must have good organ function, no major mutations in certain genes, and agree to use contraception. Excluded are those with specific gene mutations or amplifications, prior treatment with both TAS-102 and regorafenib, inability to swallow tablets, uncontrolled illnesses or conditions that could affect the trial's outcomes.

What is being tested?

The trial is testing if panitumumab retreatment is more effective than standard treatments (regorafenib or TAS-102) for metastatic colorectal cancer without resistance mutations. Panitumumab may inhibit tumor growth by blocking growth factors; regorafenib might stop tumors by interfering with these factors; TAS-102 aims to kill or halt cancer cell division.

What are the potential side effects?

Panitumumab can cause skin reactions and magnesium deficiency. Regorafenib may lead to hand-foot skin reactions, high blood pressure, fatigue, diarrhea. TAS-102 side effects include low blood counts leading to infections or bleeding problems as well as nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My white blood cell count is healthy without needing medication.

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My cancer is wild-type for KRAS, NRAS, and BRAF based on tests.

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It's been over 90 days since my last EGFR therapy before my blood test.

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I have not taken anti-VEGF drugs like bevacizumab.

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My cancer did not respond or I couldn't tolerate specific chemotherapy and targeted therapy.

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I am 18 years old or older.

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It's been over 90 days since my last EGFR therapy before my blood test.

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My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.

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I have a tumor that can be measured and has not been treated with radiation, or it has grown since being radiated.

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My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My cancer is wild-type for KRAS, NRAS, and BRAF based on tests from my tumor tissue.

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My cancer progressed after 3+ months of anti-EGFR treatment.

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I have been treated with a medication like 5-fluorouracil or capecitabine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious wound or fracture that is not healing.

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I have not had severe bleeding in the last 4 weeks.

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I haven't needed strong heart rhythm medications in the last 6 months.

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My cancer has spread to my brain.

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I have not had major surgery or significant injury within the last 28 days, or 56 days for specific surgeries.

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I have a known history of HIV, hepatitis B or C, or another serious infection needing ongoing treatment.

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I cannot swallow pills.

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I have a history of lung scarring or inflammation.

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My blood pressure is high (>150/90 mm Hg) despite taking medication.

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I haven't had cancer treatment like radiation or chemotherapy in the last 3 weeks.

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I am not pregnant, not nursing, and willing to use contraception due to the study's risks.

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My cancer has a specific gene change detected by a blood test.

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I am on blood thinners like warfarin.

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I do not have a severe ongoing infection.

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I have a history of bleeding or clotting disorders.

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I haven't taken strong CYP3A4 drugs in the last week.

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I have a history of problems absorbing nutrients.

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My cancer's genetic test shows less than 0.5% mutation in any gene.

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I have been diagnosed with heart failure that affects my daily activities.

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I haven't had a stroke, heart attack, or any major heart procedures in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Clinical Benefit Rate

Incidence of Adverse Events

Overall Response Rate (ORR)

+2 more

Other study objectives

Cell Free Tumor Deoxyribonucleic Acid (cfDNA)

Circulating Protein Studies

Tumor Tissue Studies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (panitumumab)Experimental Treatment3 Interventions

Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (regorafenib, trifluridine and tipiracil hydrochloride)Active Control4 Interventions

Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panitumumab

2017

Completed Phase 3

~7150

0 / 35Eligibility criteria met