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Amivantamab SC for Cancer (PALOMA Trial)
PALOMA Trial Summary
This trial is testing a new way to give amivantamab, a cancer medicine, under the skin instead of through an IV. They want to see if it is safe and works the same as the IV form.
PALOMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPALOMA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PALOMA Trial Design
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Who is running the clinical trial?
Media Library
- I am a man who will use a condom and my partner uses birth control.I have a certain type of cancer that cannot be removed by surgery and may benefit from specific targeted therapy.I haven't had cancer treatment in the last 2 weeks or longer, depending on the treatment type, and any side effects have mostly gone away.My NSCLC with an EGFR mutation has worsened despite treatment, including an anti-EGFR TKI or chemotherapy.I have brain metastases that are stable, and I've been off or on low-dose steroids for 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to the lining of my brain and spinal cord.I am being treated for another cancer besides the one being studied.
- Group 1: Part 2: Ami-HC and Ami-HC-CF
- Group 2: Part 3: Ami-HC-CF + Lazertinib and Ami-HC+ Lazertinib
- Group 3: Part 1: Ami-LC-MD and Ami-LC
- 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
Are there available slots for participants in this research?
"According to clinicaltrials.gov, the trial is actively recruiting participants since it was initially posted on November 10th 2020 and updated as recently as November 9th 2022."
Is the scope of this clinical trial widespread in Canada?
"Seven medical centres are operating in this trial, including Cedars Sinai Medical Center (West Hollywood), Providence Portland Medical Center (Portland), and Langone Health at NYU School of Medicine (New york). Additionally, there are 4 other sites."
What kind of risks are associated with the utilization of Ami-LC?
"Based on the existing evidence, our team assigned Ami-LC a safety score of 1 since this is an initial phase trial with limited data corroborating its efficacy and security."
What is the total capacity of participants for this research trial?
"Affirmative. Clinicaltrials.gov provides evidence that this trial, whose inception was on November 10th 2020, is actively recruiting patients. Seven different clinical sites are admitting up to 196 participants in total."
What is the ultimate goal of this clinical experiment?
"This trial will monitor a Cycle 4 (28 days) timespan to assess the primary outcome of Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough). Secondary objectives involve evaluating Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies, Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State, as well as Epidermal Growth Factor Receptor (EGFR) concentrations."
Is this experiment unprecedented in the medical field?
"Ami-LC has been subject to 9 clinical trials across 37 nations, with 128 cities hosting at least one. The first trial of Ami-LC was a Janssen Research & Development sponsored program that began in 2016 and involved 780 individuals, who completed Phase 1 drug approval. Of the nine studies conducted since then, six have concluded their research data collection phases."
Could you provide an overview of prior research that has focused on Ami-LC?
"Currently, 9 clinical trials studying Ami-LC are active with 3 of those being in a Phase 3. These studies have 1036 locations available worldwide; however, many are located in Sutton, Ontario."
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