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Monoclonal Antibodies

Tucatinib for Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 49.3 months
Awards & highlights

Study Summary

This trial is studying how well tucatinib works with or without trastuzumab to treat participants with HER2-positive metastatic colorectal cancer.

Eligible Conditions
  • Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49.3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49.3 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
Confirmed Objective Response Rate (cORR) Per RECIST 1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
Secondary outcome measures
Duration of Response (DOR) Per RECIST 1.1 According to BICR Assessment
Number of Participants With AEs Resulting in Dose Modification
Number of Participants With Adverse Events (AEs)
+5 more

Side effects data

From 2023 Phase 2 trial • 117 Patients • NCT03043313
64%
Diarrhoea
43%
Fatigue
34%
Nausea
21%
Infusion related reaction
20%
Pyrexia
19%
Chills
19%
Decreased appetite
19%
Dermatitis acneiform
17%
Hypertension
16%
Arthralgia
16%
Vomiting
16%
Back pain
16%
Cough
14%
Abdominal pain
14%
Constipation
14%
Dyspnoea
13%
Myalgia
10%
Anxiety
10%
Anaemia
9%
Headache
9%
Pruritus
9%
Dry skin
9%
Pain in extremity
8%
Rash maculo-papular
8%
Peripheral sensory neuropathy
8%
Insomnia
8%
Influenza like illness
8%
Dehydration
8%
Oedema peripheral
8%
Nasal congestion
7%
Productive cough
7%
Upper-airway cough syndrome
7%
Weight decreased
7%
Muscle spasms
7%
Epistaxis
6%
Hypokalaemia
6%
Rhinitis allergic
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Dry mouth
5%
Oropharyngeal pain
5%
Ejection fraction decreased
5%
Dizziness
5%
Nephrolithiasis
5%
Rash
5%
Abdominal pain upper
5%
Musculoskeletal chest pain
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Blood creatinine increased
3%
Pollakiuria
3%
Asthenia
3%
Vision Blurred
3%
Dysuria
3%
Flatulence
3%
Non-cardiac chest pain
3%
Gastrooesophageal reflux disease
3%
Large intestinal obstruction
3%
Dyspepsia
3%
Fall
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Herpes zoster
2%
Abdominal distension
2%
Thrombocytopenia
2%
Abdominal discomfort
2%
Rectal haemorrhage
2%
Influenza
2%
Blood alkaline phosphatase increased
2%
Blepharospasm
2%
Rhinitis
2%
Gastrointestinal pain
2%
Nail infection
2%
Pelvic pain
2%
Peripheral swelling
2%
COVID-19 pneumonia
2%
Onychomadesis
2%
Rectal perforation
2%
Muscular weakness
2%
Weight increased
2%
Dysphonia
2%
Erythema
2%
Nail disorder
2%
Urticaria
2%
Hypoalbuminaemia
2%
Dyspnoea exertional
2%
Pulmonary embolism
2%
Sinus pain
1%
Acute kidney injury
1%
Cholangitis
1%
Bile duct stone
1%
Hypotension
1%
Sepsis
1%
Cancer pain
1%
Angina unstable
1%
Colitis
1%
Gastrointestinal obstruction
1%
Kidney infection
1%
Renal colic
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tucatinib+Trastuzumab (Cohorts A+B)
Cohort C (Pre-Crossover)
Cohort C (Post-Crossover)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Tucatinib MonotherapyExperimental Treatment1 Intervention
Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab.
Group II: Cohort B: Tucatinib + TrastuzumabExperimental Treatment2 Interventions
Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Group III: Cohort A: Tucatinib + TrastuzumabExperimental Treatment2 Interventions
Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Tucatinib
2017
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,040 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,155 Total Patients Enrolled
Academic and Community Cancer Research UnitedOTHER
53 Previous Clinical Trials
5,019 Total Patients Enrolled

Media Library

Trastuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03043313 — Phase 2
Colorectal Cancer Research Study Groups: Cohort A: Tucatinib + Trastuzumab, Cohort B: Tucatinib + Trastuzumab, Cohort C: Tucatinib Monotherapy
Colorectal Cancer Clinical Trial 2023: Trastuzumab Highlights & Side Effects. Trial Name: NCT03043313 — Phase 2
Trastuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043313 — Phase 2

Frequently Asked Questions

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

Is enrollment for this investigation being accepted at present?

"This research is no longer looking for participants. It was initially advertised on June 23rd 2017 and the last edits were made on 6th of June 2022. If you are in search of other trials, there are currently 860 studies that accept individuals with colorectal cancer and 199 studies actively recruiting patients to test Tucatinib."

Answered by AI

Has Tucatinib been explored in any other medical experiments?

"Originally explored by Ospedale di Circolo e Fondazione Macchi in 1999, the investigation of tucatinib has seen 362 completed studies. Currently, 199 active trials are underway with a significant portion centered around Tyler, Texas."

Answered by AI

Has Tucatinib been granted the stamp of approval from the FDA?

"Tucatinib has been given a score of 2 due to there being some evidence for its safety but no research which indicates that it is efficacious."

Answered by AI

What medical purpose does Tucatinib typically serve?

"Tucatinib is frequently administered to treat breast conditions, but it has also been found effective for high risk of recurrence cases, as first line treatment and post-surgery."

Answered by AI

How many medical facilities are currently conducting this research?

"Although there are 37 overall clinical sites, a few of these include Texas Oncology - Tyler in Tyler, Comprehensive Cancer Centers of Nevada in Las Vegas and Oregon Health and Science University located in Portland."

Answered by AI

To what extent is the trial population participating in this research?

"Unfortunately, this trial is no longer recruiting volunteers. Initially posted on June 23rd 2017 and most recently updated on 6/6/2022, it has closed its doors to new participants. For those seeking alternatives, there are 860 studies for colorectal cancer and 199 trials featuring Tucatinib that can still be applied to."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
2017. "Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03043313.
~15 spots leftby Apr 2025
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