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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 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.

Timeline

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

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 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
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
~1600
Panitumumab
2020
Completed Phase 3
~6490

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,293 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,103 Total Patients Enrolled
Christine ParseghianPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Panitumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03087071 — Phase 2
Colorectal Cancer Research Study Groups: Cohort 3 (panitumumab), Cohort 2 (panitumumab, trametinib), Cohort 1 (panitumumab)
Colorectal Cancer Clinical Trial 2023: Panitumumab Highlights & Side Effects. Trial Name: NCT03087071 — Phase 2
Panitumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03087071 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of trial been conducted before?

"Since 2011, panitumumab has been under clinical trials by various research teams. The first study was conducted by Amgen and it resulted in the drug being approved for Phase 2 use. As of now, there are 131 active studies being done on panitumumab in 1216 cities across 42 countries."

Answered by AI

Has Panitumumab recieved government approval for use?

"Panitumumab is a Phase 2 medication, so while there is some evidence backing its safety, there is none to support its efficacy. We scored it as a 2."

Answered by AI

Are there similar Panitumumab clinical trials that have been conducted in the past?

"There are a total of 131 studies being done on panitumumab, 9 of which are currently in phase 3. Many of these trials are based out of Duarte, California; however, there are 6282 locations running trials for this treatment worldwide."

Answered by AI

How many people have been accepted into this research project?

"That is correct, the information available on clinicaltrials.gov indicates that this study is seeking patients for participation. This trial was originally posted on December 29th, 2017 and has since been updated on July 5th, 2022. There is currently a goal to enroll 84 people at 1 location."

Answered by AI

Are people still able to sign up for this clinical trial?

"The most recent information from clinicaltrials.gov suggests that this clinical trial is recruiting patients as of right now. The original posting was on December 29th, 2017 with the latest update being July 5th, 2022."

Answered by AI

What are the most popular reasons why people use Panitumumab?

"Patients with unresectable melanoma, metastatic colorectal cancer (CRC), and progression after treatment with fluoropyrimidine, oxaliplatin and irinotecan can be treated using panitumumab."

Answered by AI
~7 spots leftby Jan 2025