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Trastuzumab Deruxtecan + Neratinib for Cancer
Study Summary
This trial is testing the safety and effectiveness of combining neratinib with trastuzumab deruxtecan to treat patients with metastatic or unresectable solid tumors that have a change in the HER2 gene.
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.Trial Design
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- I have a tumor that can be safely biopsied.I have recovered from serious side effects of my previous cancer treatment.I have not had major surgery or radiation recently.I am 18 years old or older.I have chronic hepatitis B but my viral load is undetectable.I have another type of cancer that could affect my current treatment.My heart condition allows me to perform daily activities with slight limitations.I am HIV-positive but stable on my medication and healthy.I am not taking any medications that could interfere with the trial.My tumor is HER2 positive based on specific tests.I have previously been treated with neratinib or DS-8201a.My kidney function is within the required range.I have a long-term stomach problem that mainly causes diarrhea.I cannot swallow pills.I am mostly active and can carry out light work.My brain metastases have been treated.I have had at least one treatment for my cancer after it spread.My cancer has spread or cannot be removed, and this trial is considered my best next treatment option.
- Group 1: Treatment (neratinib, trastuzumab deruxtecan)
- 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
Does this research study currently accept participants?
"The data on clinicaltrials.gov affirms that this study is still open to enrolment and has been since June 17th 2022; with the last update occurring September 28th 2022."
How many participants are being recruited for this investigation?
"Affirmative. According to information available on clinicaltrials.gov, this investigation began enrolling participants after it was posted in June of 2022 and is still recruiting today. The study requires 18 individuals from two different medical facilities for its completion."
Has the Trastuzumab Deruxtecan drug been sanctioned by the U.S. Food and Drug Administration?
"Trastuzumab Deruxtecan's safety has been assessed as a 1 on the scale of 1-3 due to its position in Phase 1 trials. This indicates that there is limited information regarding both its efficacy and safety."
To what end does this clinical experiment aim to accomplish?
"The primary assessment of this trial within the span of 42 days is to gauge incidence of dose-limiting toxicities. Secondary objectives include progression-free survival, as measured by RECIST v 1.1 with Kaplan Meier product limit methods, and pharmacokinetic profiles for both DS - 8201a and neratinib alongside their respective metabolites using descriptive statistics along with ANOVA & regression model analysis in order to analyse any correlations between PK biomarker levels and anti-tumor efficacy. The endpoint data will be analysed including mean values, standard deviation, median value, minimum & maximum value respectively."
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