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Ulixertinib + Palbociclib for Pancreatic Cancer
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
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.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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Who is running the clinical trial?
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- I am willing to avoid certain fruits for the study.I cannot or will not stop taking drugs that could affect the study medication.My condition did not improve after treatment with a PD1/PD-L1 inhibitor.I have recovered from the side effects of my last cancer treatment.I have not had major surgery within the last 34 days.I haven't taken any herbal or dietary supplements in the last 7 days.My organs are functioning well.I have pancreatic cancer or melanoma and have been treated for it after it spread.My melanoma cannot be removed by surgery and is in stage III or IV with certain genetic changes.I have been treated with ipilimumab before.My cancer can be measured by standard criteria.I am a woman who can have children and have a negative pregnancy test.I have a digestive issue that affects how my body absorbs medicine.I have an autoimmune disease and take steroids for it.My heart is strong, with a good pumping ability and normal heart rhythm.I have or am at risk for eye conditions like RVO or CSR.I haven't taken any cancer drugs or experimental treatments in the last 28 days.I have another cancer that is growing and needs treatment.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.My cancer has spread to my brain under certain conditions.My advanced cancer does not respond to standard treatments.You are expected to live for at least 12 more weeks.I cannot swallow pills.You have mental health or social issues that might make it hard for you to follow the study rules.I am willing and able to follow the study's requirements.I agree to use birth control or abstain from sex during and up to 120 days after treatment.I agree to give my previous biopsy samples and undergo new biopsies for research.
- Group 1: Open-label, single arm Phase I
- 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
What medical conditions can Ulixertinib be used to alleviate?
"Ulixertinib is often prescribed to treat breast conditions, yet it has also been demonstrated as a viable treatment option for malignant neoplasms, postmenopause cases and even complex advance directives."
Who has the eligibility to partake in this medical study?
"This clinical trial is open to 45 participants afflicted with pancreatic cancer, all of whom must be 18 years or older. Key requirements for eligibility include providing written informed consent and HIPAA authorization, having an Eastern Cooperative Oncology Group Performance Status no greater than 2, exhibiting measurable or non-measurable (but evaluable) disease according to RECIST v1.1 guidelines depending on the cohort they are in, demonstrating life expectancy of at least 12 weeks as well as recovered from reversible acute toxic effects of anti-cancer treatment up to Grade 1 toxicity or baseline levels respectively; hemoglobin ≥ 9 g/dL, absolute neutrophil"
Are there any enrolment opportunities open for this investigation at present?
"Affirmative, according to the clinicaltrials.gov website, this trial is recruiting now. It was first made public on January 30th 2018 and recently updated on November 18th 2022. A total of 45 participants are needed from a single location for enrolment."
How many participants are engaged in this experimentation?
"Affirmative. According to the information on clinicaltrials.gov, this investigation is still searching for individuals to participate in the study which was initially published on January 30th 2018 and last modified November 18th 2022. 45 applicants are required from 1 medical site."
Is this experiment open to participants aged 55 and up?
"The eligibility criteria for this clinical trial stipulates that only those between 18 to 99 years of age can enroll. Subsequently, there are separate trials available for individuals below the age of 18 and people beyond 65."
Are there any precedent studies that have utilized Ulixertinib?
"As of now, 137 clinical trials are underway that evaluate the effects of Ulixertinib. Of those, 16 have reached Phase 3 and a significant number (6715) of medical centres worldwide aid in these studies. The majority are located in Burgas, New jersey."
Has Ulixertinib been granted sanction from the Food and Drug Administration?
"There is a dearth of evidence to back up the safety and efficacy of Ulixertinib, so it was given a rating of 1 on our team's scale."
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