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Monoclonal Antibodies
Tucatinib + Trastuzumab for Rectal Cancer
Phase 2
Recruiting
Led By Andrea Cercek, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 21 +/- 4 weeks
Awards & highlights
Study Summary
This trial suggests a combo of trastuzumab/tucatinib with chemo may help treat rectal cancer.
Who is the study for?
Adults with HER2-positive rectal adenocarcinoma, without distant metastases and measurable disease. Participants must be over 18, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. Women of childbearing potential must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining tucatinib and trastuzumab with standard chemotherapy (CAPOX) in treating rectal cancer. Researchers hope this combination will benefit participants by targeting specific aspects of cancer cells.See study design
What are the potential side effects?
Potential side effects may include diarrhea, liver enzyme elevation, fatigue, mouth sores from chemotherapy, heart issues related to trastuzumab, hand-foot syndrome from capecitabine, nerve damage from oxaliplatin, and possible interactions affecting drug metabolism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 +/- 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 +/- 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical complete response of study participants
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participant with Rectal AdenocarcinomaExperimental Treatment2 Interventions
Participants will have HER2-positive locally advanced rectal adenocarcinoma.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,852 Total Patients Enrolled
Andrea Cercek, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer
9 Previous Clinical Trials
2,049 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to distant parts of my body.I am fully active or can carry out light work.My tumor is causing blockage in my intestines.I have a history of HIV or active Hepatitis B or C.My rectal cancer has come back.I haven't had another type of cancer in the last 5 years.My organs are functioning well, as confirmed by recent tests.I have had radiation, chemotherapy, or surgery for rectal cancer before.I have not received a live vaccine in the last 30 days.My cancer is located within 15 cm of the anal opening and is at a specific stage.I haven't taken specific drugs that affect liver enzymes recently.My rectal cancer is HER2 positive.I am 18 years old or older.I am not currently using any other cancer treatments or experimental therapies.I have not had major surgery or a significant injury in the last 28 days.I am currently being treated for an infection.I cannot swallow pills or have a major gut issue affecting medicine absorption.I am not pregnant, breastfeeding, nor planning to conceive or father a child during the trial.My cancer is a type of rectal cancer confirmed by tissue analysis.I have a long-term liver condition.
Research Study Groups:
This trial has the following groups:- Group 1: Participant with Rectal Adenocarcinoma
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.
Can you explain the safety level of those involved in the Participant with Rectal Adenocarcinoma study?
"The safety of those with rectal adenocarcinoma was assessed as a 2 due to the existent data supporting its security, yet lacking evidence for efficacy in this Phase 2 trial."
Answered by AI
Are there opportunities for individuals to register at present for this clinical experiment?
"Affirmative, according to data found on clinicaltrials.gov this medical trial is currently open for enrollment and was originally posted December 30th 2022. Last updated January 3rd 2023, the study seeks to recruit 37 patients from 7 distinct sites."
Answered by AI
Are there numerous locations in Canada where this research is being conducted?
"This clinical trial is presently open at 7 sites, including Middletown, Montvale and Commack. To reduce the burden of travelling to these locations, it is prudent for potential participants to select a site in close proximity to them."
Answered by AI
How many people can partake in this experiment?
"Indeed, according to clinicaltrials.gov, this investigation is actively open for enrollment. This trial was initially published on December 30th 2022 and last edited on January 3rd 2023; it seeks 37 patients from 7 eligible sites."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
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