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Monoclonal Antibodies
Tucatinib + Trastuzumab + TAS-102 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
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2 (Form is available on the ACCRU website)
Previous treatment with or contraindication to: A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), Oxaliplatin, Irinotecan, An anti-VEGF biological therapy (including but not limited to bevacizumab, ramucirumab, or ziv-aflibercept), If the tumor has deficient mismatch repair proteins or is microsatellite instability (MSI)-High based on tumor tissue testing, an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to see if it can better shrink tumors in patients with HER2 positive colorectal cancer that has spread and who have one of four gene mutations.
Who is the study for?
Adults with HER2 positive metastatic colorectal cancer and specific gene mutations (PIK3CA, KRAS, NRAS, or BRAF V600) detected in blood. They must have a life expectancy of at least 3 months, measurable disease by RECIST criteria, adequate organ function, agree to use contraception if sexually active and provide consent for follow-up and research purposes.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining tucatinib with trastuzumab and TAS-102 (trifluridine/tipiracil hydrochloride) in shrinking tumors. Tucatinib blocks abnormal protein signaling; trastuzumab targets HER2 receptors on tumor cells; TAS-102 stops tumor growth.See study design
What are the potential side effects?
Potential side effects include digestive issues from TAS-102; heart problems due to trastuzumab's effect on cardiac receptors; skin reactions or liver toxicity from tucatinib. Side effects vary based on individual patient health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I cannot use certain cancer drugs due to past reactions or they are not suitable for my cancer type.
Select...
My tumor is HER2 positive based on specific lab tests.
Select...
I am 18 years old or older.
Select...
My blood test shows I have a specific gene mutation (PIK3CA, KRAS, NRAS, or BRAF V600).
Select...
My cancer in the colon or rectum has been confirmed by lab tests and has spread.
Select...
My kidney function, measured by creatinine clearance, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival rate
Secondary outcome measures
Clinical benefit
Incidence of adverse events
Overall response
+1 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tucatinib, trastuzumab, TAS-102)Experimental Treatment3 Interventions
Patients receive tucatinib PO BID, trastuzumab IV over 30-90 minutes on days 1 and 15, and TAS-102 PO BID on days 1-5 and 8-12. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Tucatinib
2017
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,459 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,106 Total Patients Enrolled
John H StricklerPrincipal InvestigatorAcademic and Community Cancer Research United
4 Previous Clinical Trials
405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any medications that the study prohibits.I have recovered from previous treatment side effects, except for hair loss, nerve issues from oxaliplatin, or minor electrolyte problems.I am able to care for myself and perform daily activities.I haven't had a stroke, heart attack, or any major heart or blood vessel procedures in the last 6 months.I cannot use certain cancer drugs due to past reactions or they are not suitable for my cancer type.My tumor is HER2 positive based on specific lab tests.I have a history of HIV, hepatitis B or C, or another serious infection needing treatment.I have had brain metastases, but they are now treated and I haven't needed steroids for over 30 days.I am willing and able to follow the study rules.I do not have severe heart problems that could affect my participation.I have been diagnosed with heart failure that affects my daily activities.I am 18 years old or older.I have a serious wound or fracture that is not healing.I am not taking any experimental drugs for my cancer.My heart pumps well, with an ejection fraction of 50% or higher.I am not pregnant or breastfeeding.My blood test shows I have a specific gene mutation (PIK3CA, KRAS, NRAS, or BRAF V600).I have not had major surgery or significant injury within the last 28 days, or 56 days for specific surgeries.I haven't had cancer treatment like radiation or chemotherapy in the last 3 weeks.I haven't taken strong drugs that affect liver enzymes recently.My cancer in the colon or rectum has been confirmed by lab tests and has spread.I have been treated with a HER2-targeting drug before.I have no other cancers except possibly treated skin cancer, superficial bladder tumor, or cervical cancer in-situ.I agree to use barrier contraception during the study and for 4 months after.I am willing to sign the consent form within 30 days before joining.I cannot swallow pills or have a stomach condition that affects medication absorption.My kidney function, measured by creatinine clearance, is within the normal range.I have a chronic liver condition or autoimmune hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tucatinib, trastuzumab, TAS-102)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Trastuzumab considered secure for patients?
"Trastuzumab's safety was assessed and scored as a 2, given that there is some evidence of its security but no proof yet that it works."
Answered by AI
Is enrollment still open for this research endeavor?
"As per the data available on clinicaltrials.gov, enrollment for this investigation has been closed since October 18th 2022. This trial was initially posted on November 30th 2022. Nevertheless, there are still 1577 medical studies that are presently accepting participants."
Answered by AI
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