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Panitumumab + Trametinib for Colorectal Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2009 Phase 3 trial • 463 Patients • NCT00113763Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Cohort 3 (panitumumab)
- Group 2: Cohort 2 (panitumumab, trametinib)
- Group 3: Cohort 1 (panitumumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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