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Monoclonal Antibody
Tucatinib + Trastuzumab Emtansine for Brain Metastases
Phase 2
Recruiting
Led By Ecaterina Dumbrava, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will test if two drugs can help control tumors that have spread to the brain.
Who is the study for?
This trial is for adults (18+) with HER2-positive metastatic solid tumors that have spread to the brain. Participants must be willing to use birth control and undergo biopsies, have a life expectancy of at least 3 months, and their body should be functioning well enough to handle the trial. People can't join if they're pregnant, breastfeeding, or planning pregnancy; are on high-dose steroids; have uncontrolled seizures due to brain metastases; or have had recent cancer treatments.Check my eligibility
What is being tested?
The study is testing tucatinib combined with ado-trastuzumab emtansine (T-DM1) in patients whose solid tumors have spread to the brain. The goal is to see if these drugs can help manage the disease.See study design
What are the potential side effects?
Possible side effects include allergic reactions, issues from biopsies like bleeding or infection, fatigue from treatment, liver problems due to medications used in this trial, and potential heart or lung complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tucatinib and Adotrastuzumab Emtansine (T-DM1)Experimental Treatment2 Interventions
Each study cycle is 21 days (3 weeks)
Participants will take tablets of tucatinib two (2) times a day, about 8-12 hours apart. Participants will receive T-DM1 by vein over about 30 minutes on Day 1 of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Find a Location
Who is running the clinical trial?
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,127 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,287 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,869 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with a certain level of physical health and expected lifespan.I have a chronic liver disease or a known viral infection.My blood and organ tests are within normal ranges.I may or may not have had HER2-targeted treatments before.I do not have serious heart conditions or recent heart attacks.I have a serious heart or lung condition.I have recently used specific enzyme inhibitors or inducers.I am willing to have a biopsy for the study.I have large or serious brain lesions or need strong medication for them.My cancer is HER2-positive and has spread to other parts of my body.I cannot swallow pills or have a GI condition affecting drug absorption.I don't have lasting side effects from previous cancer treatments.My seizures are not well-managed or my brain cancer is getting worse.I have not been treated for another cancer within the last year.I have recently used cancer drugs or been part of a drug trial.
Research Study Groups:
This trial has the following groups:- Group 1: Tucatinib and Adotrastuzumab Emtansine (T-DM1)
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.
Has the FDA granted clearance for Tucatinib and Adotrastuzumab Emtansine (T-DM1)?
"The safety of Tucatinib and Adotrastuzumab Emtansine (T-DM1) was rated a 2, as this is an ongoing Phase 2 trial. So far data from the study has indicated that it may be safe to use but no efficacy information exists yet."
Answered by AI
Are there any slots still available for this trial?
"Currently, this medical trial is not enlisting new patients. It was initially posted on June 30th 2023 and last updated December 30th 2022. Nonetheless, there are 907 other clinical trials actively seeking volunteers at the moment."
Answered by AI
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