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Monoclonal Antibodies

Panitumumab + Trametinib for Colorectal Cancer

Phase 2

Waitlist Available

Led By Christine Parseghian

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Serum creatinine performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN, or have calculated creatinine clearance (using Cockcroft-Gault formula) of >= 50 mL/minute

Must not have

Impaired cardiac function or clinically significant cardiac disease, as defined: a) left ventricular ejection fraction < lower limit of normal (LLN) on multiple gated acquisition scan (MUGA) or echocardiogram; b) congenital long QT syndrome or family history of unexpected sudden cardiac death; c) corrected QT (QTc) corrected with Bazett's formula (QTcB) >= 480 ms.; d) history or evidence of current clinically significant uncontrolled arrhythmias; note subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible; e) history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization; f) history or evidence of current >= class II congestive heart failure as defined by New York Heart Association (NYHA); g) treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy; h) patients with intra-cardiac defibrillators

Current use of a prohibited medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining two drugs, panitumumab and trametinib, is more effective than panitumumab alone in treating patients with stage IV colorectal cancer.

Who is the study for?

This trial is for adults with stage IV colorectal cancer who have specific gene mutations (KRAS, NRAS, BRAF, MEK) and have progressed after anti-EGFR therapy. They must not have had certain treatments recently and should be generally healthy with good organ function. Women of childbearing age need a negative pregnancy test and agree to use contraception.

What is being tested?

The study tests the effectiveness of panitumumab alone or combined with trametinib in treating advanced colorectal cancer. Panitumumab is an immunotherapy drug while trametinib blocks enzymes that help tumor cells grow. The goal is to see if combining these drugs improves patient outcomes.

What are the potential side effects?

Panitumumab can cause skin reactions, low magnesium levels, fatigue, and infusion-related reactions. Trametinib may lead to rash, diarrhea, high blood pressure and heart problems among other side effects. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function tests are within the required range.

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My cancer worsened after anti-EGFR therapy, not stopped for other reasons.

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I can swallow pills and don't have major stomach or bowel issues.

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My colorectal cancer has spread and this was confirmed by tests.

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My cancer does not have mutations in EGFR, KRAS, NRAS, or BRAF.

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My side effects from previous treatments are mild, except for hair loss or nerve pain.

Exclusion Criteria

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

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I am not taking any medications that are not allowed in the study.

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I am unable or unwilling to follow the study's requirements.

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I was treated again with anti-EGFR therapy after my cancer progressed.

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I have brain or spinal cord cancer symptoms or untreated cancer spread.

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I have had interstitial lung disease or pneumonitis.

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I have had a blockage in the veins of my retina.

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I have had an organ transplant or have a condition that weakens my immune system.

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I have never been treated with MEK or ERK inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response rate

Secondary study objectives

Complete response

Overall survival (OS)

Partial response

+2 more

Side effects data

From 2009 Phase 3 trial • 463 Patients • NCT00113763

66%

ERYTHEMA

58%

PRURITUS

57%

DERMATITIS ACNEIFORM

28%

ANOREXIA

26%

FATIGUE

25%

PARONYCHIA

24%

ABDOMINAL PAIN

22%

RASH

22%

NAUSEA

21%

DIARRHOEA

20%

SKIN FISSURES

19%

CONSTIPATION

18%

EXFOLIATIVE RASH

18%

VOMITING

16%

PYREXIA

16%

DYSPNOEA

15%

COUGH

14%

ACNE

13%

COLORECTAL CANCER METASTATIC

12%

OEDEMA PERIPHERAL

12%

ASTHENIA

10%

BACK PAIN

10%

NAIL DISORDER

10%

DRY SKIN

SKIN EXFOLIATION

ABDOMINAL PAIN UPPER

INSOMNIA

COLORECTAL CANCER

STOMATITIS

SKIN ULCER

GENERAL PHYSICAL HEALTH DETERIORATION

GROWTH OF EYELASHES

MUCOSAL INFLAMMATION

JAUNDICE

ANXIETY

HEPATOMEGALY

WEIGHT DECREASED

INTESTINAL OBSTRUCTION

ANAEMIA

ASCITES

HEPATIC FAILURE

DEHYDRATION

COMA

GASTROINTESTINAL OBSTRUCTION

RECTAL HAEMORRHAGE

HYPERBILIRUBINAEMIA

CACHEXIA

METASTASES TO LIVER

METASTASES TO LUNG

HEMIPARESIS

EPILEPSY

DEPRESSED LEVEL OF CONSCIOUSNESS

HEPATIC ENCEPHALOPATHY

PULMONARY EMBOLISM

DEEP VEIN THROMBOSIS

JUGULAR VEIN THROMBOSIS

100%

80%

60%

40%

20%

Study treatment Arm

Panitumumab Plus BSC

BSC Alone

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (panitumumab)Experimental Treatment2 Interventions

Patients without EGFR ectodomain, KRAS, NRAS, or BRAF mutation receive panitumumab as in Cohort 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Cohort 2.

Group II: Cohort 2 (panitumumab, trametinib)Experimental Treatment3 Interventions

Patients with KRAS, NRAS, or BRAF mutation receive trametinib PO QD on days 1-14 and panitumumab as in Cohort 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Group III: Cohort 1 (panitumumab)Experimental Treatment2 Interventions

Patients with EGFR ectodomain mutation receive panitumumab IV over 30-90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Cohort 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

Panitumumab

2017

Completed Phase 3

~7150