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Monoclonal Antibodies
Patritumab Deruxtecan for Brain Tumor (PARAMETer Trial)
Phase < 1
Waitlist Available
Research Sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP
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 40 days
Awards & highlights
PARAMETer Trial Summary
This trial studies if a drug can reach brain tumors in one dose before surgery.
Who is the study for?
This trial is for adults with new or returning brain tumors that can be removed by surgery. They should have minimal symptoms, agree to a craniotomy, and use birth control if needed. Eligible cancers include melanoma, stomach, breast, colorectal, bladder, ovarian cancer etc., with good performance status and organ function.Check my eligibility
What is being tested?
The study tests patritumab deruxtecan (HER3-DXd) in patients before they undergo brain tumor removal surgery. It aims to see if the drug reaches the brain tissue after one dose.See study design
What are the potential side effects?
Potential side effects of patritumab deruxtecan may include reactions related to drug infusion, issues affecting organs like lungs or liver due to pre-existing conditions or allergies specific to this medication.
PARAMETer Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain
Secondary outcome measures
Assess the evidence of tumor cell death via histopathological examination and measurement of γH2AX levels in tumor tissue.
Brain
Craniotomy
PARAMETer Trial Design
1Treatment groups
Experimental Treatment
Group I: Patritumab deruxtecanExperimental Treatment1 Intervention
15 participants with surgically-resectable brain metastases from multiple solid tumor primary histologies known to express HER3 will be treated. Patritumab deruxtecan (HER3-DXd) will be administered IV 5.6 mg/kg as a single dose 1-3 days prior to planned craniotomy and resection of BrM. Participants will undergo specimen collection prior to and during the planned craniotomy, including tumor, blood, and cerebrospinal fluid (CSF).
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Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
392 Previous Clinical Trials
411,350 Total Patients Enrolled
Mustafa Khasraw, MBChB, MD, FRCP, FRACPLead Sponsor
3 Previous Clinical Trials
106 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,282 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am willing and able to undergo brain surgery.I am mostly able to care for myself.I have a new or returning brain tumor that can be removed by surgery.I do not have major heart problems before starting the treatment.I still have side effects from past cancer treatments.My brain cancer symptoms are not present or are well-managed.My blood tests show my organs and bone marrow are working well.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have an active Hepatitis B or C infection.My cancer is one of the specified types, such as melanoma or breast cancer.I do not have severe illnesses like heart disease, recent cancer, or lung problems.I don't have any health issues that could make this trial unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Patritumab deruxtecan
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.
Is enrollment still open for this clinical trial?
"Affirmative. The clinical trials website reflects that this particular medical research trial is not currently recruiting participants, as the last update was on November 10th 2022. Fortunately, there are 885 other studies which are actively enrolling patients at present."
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