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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Complete response
Overall survival (OS)
Partial response
+2 moreSide effects data
From 2009 Phase 3 trial • 463 Patients • NCT0011376366%
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
9%
SKIN EXFOLIATION
8%
ABDOMINAL PAIN UPPER
7%
INSOMNIA
7%
COLORECTAL CANCER
7%
STOMATITIS
6%
SKIN ULCER
6%
GENERAL PHYSICAL HEALTH DETERIORATION
6%
GROWTH OF EYELASHES
6%
MUCOSAL INFLAMMATION
6%
JAUNDICE
6%
ANXIETY
5%
HEPATOMEGALY
5%
WEIGHT DECREASED
5%
INTESTINAL OBSTRUCTION
5%
ANAEMIA
2%
ASCITES
2%
HEPATIC FAILURE
2%
DEHYDRATION
1%
COMA
1%
GASTROINTESTINAL OBSTRUCTION
1%
RECTAL HAEMORRHAGE
1%
HYPERBILIRUBINAEMIA
1%
CACHEXIA
1%
METASTASES TO LIVER
1%
METASTASES TO LUNG
1%
HEMIPARESIS
1%
EPILEPSY
1%
DEPRESSED LEVEL OF CONSCIOUSNESS
1%
HEPATIC ENCEPHALOPATHY
1%
PULMONARY EMBOLISM
1%
DEEP VEIN THROMBOSIS
1%
JUGULAR VEIN THROMBOSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panitumumab Plus BSC
BSC Alone
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
~1550
Panitumumab
2020
Completed Phase 3
~7130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,176 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,255 Total Patients Enrolled
Christine ParseghianPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are not allowed in the study.My cancer progressed after treatment with specific chemotherapy drugs or I can't tolerate some of them due to a condition or side effects.I am unable or unwilling to follow the study's requirements.My cancer has specific mutations and progressed after anti-EGFR therapy.My cancer has specific mutations in KRAS, NRAS, BRAF, or MEK genes.I was treated again with anti-EGFR therapy after my cancer progressed.I have brain or spinal cord cancer symptoms or untreated cancer spread.I have had interstitial lung disease or pneumonitis.I haven't had any cancer except for certain skin cancers or cervical cancer in situ in the last 3 years.I haven't had cancer treatment in the last 21 days and have recovered from past treatments.I have had a blockage in the veins of my retina.My cancer does not have mutations in specific genes (KRAS, NRAS, BRAF).I have recent test results for specific cancer gene mutations.I've had successful anti-EGFR therapy for colorectal cancer without worsening for 16+ weeks.I am fully active or restricted in physically strenuous activity but can do light work.My kidney function tests are within the required range.My heart's pumping ability is within the normal range.I haven't had major surgery or intense cancer treatment in the last 3 weeks.I can swallow pills and don't have major stomach or bowel issues.I have had an organ transplant or have a condition that weakens my immune system.My cancer worsened after anti-EGFR therapy, not stopped for other reasons.My liver tests are within the required range for the study.My recent liver tests show my albumin is at least 2.5 g/dL.I can sign the consent form for this study.My colorectal cancer has spread and this was confirmed by tests.I have brain metastasis that hasn't been treated or was treated within the last 3 months.I have never been treated with MEK or ERK inhibitors.My cancer does not have mutations in EGFR, KRAS, NRAS, or BRAF.My side effects from previous treatments are mild, except for hair loss or nerve pain.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (panitumumab, trametinib)
- Group 2: Cohort 3 (panitumumab)
- Group 3: Cohort 1 (panitumumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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