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Pacritinib for Myelofibrosis (PACIFICA Trial)
PACIFICA Trial Summary
This trial is testing a new drug, pacritinib, to see if it is better than the current standard of care for treating patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have severe thrombocytopenia (low platelet count). 399 patients will be enrolled and randomly assigned to either pacritinib or the current standard of care. The primary outcome measure is spleen response rate.
PACIFICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPACIFICA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT02891603PACIFICA Trial Design
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Who is running the clinical trial?
Media Library
- I haven't had serious heart issues in the last 6 months.My heart's electrical cycle is longer than normal or I have low potassium/have a history of long QT syndrome.I have an active or uncontrolled bowel disorder like Crohn's.I have completed or am willing to undergo a stem cell transplant.I have been treated with more than one JAK2 inhibitor.I haven't taken any medication that increases bleeding risk in the last 14 days.I haven't taken any medications that affect heart rhythm in the last 14 days.I haven't had cancer, except for certain skin or non-invasive cancers, or specific low-risk prostate cancers in the last 3 years.I experience significant pain, itching, or night sweats due to my condition.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.My liver and kidney functions are within the required limits.I have not had radiation to my spleen in the last 6 months.I haven't taken any myelofibrosis-specific treatment in the last 14 days.I am not allergic to pacritinib, its ingredients, or certain diarrhea medicines.I have previously taken JAK2 inhibitor medication.I have taken ruxolitinib, but never more than 10 mg per day, and for no longer than 270 days.I have taken a JAK2 inhibitor for 90 days or less.I do not have stomach or metabolic issues affecting medication absorption.I have been treated with pacritinib before.I haven't taken strong medication that affects liver enzymes in the last 14 days.I have had my spleen removed or will have it removed.Your doctor predicts that you have less than 6 months to live.I am not pregnant or breastfeeding.My condition is classified as Intermediate-1, Intermediate-2, or High risk according to DIPSS.I haven't had serious bleeding in the last 3 months not caused by surgery or injury.I have moderate to severe heart failure.My spleen is enlarged and can be felt at least 5 cm below my rib cage.I am willing and able to have many MRI or CT scans.I have been diagnosed with a type of myelofibrosis.I can and will report my symptoms using a provided tool.
- Group 1: Physician's Choice (P/C) therapy
- Group 2: Pacritinib 200 mg BID
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 any other examples of successful Pacritinib trials?
"At the moment, there are a total of 140 studies involving Pacritinib with 17 in Phase 3. Among these ongoing investigations, several are based in Houston, Texas; however, 3560 medical facilities worldwide are running trials for Pacritinib."
Are there any deleterious side effects of Pacritinib?
"Since this is a Phase 3 trial, there is some data indicating that the drug is effective and multiple rounds of safety data, our team rates Pacritinib as a 3 on our safety scale."
What conditions does Pacritinib help to treat?
"Pacritinib can be an effective treatment for patients suffering from chemoradiation, dermatitis, atopic conditions, and meningiomas."
Are there any slots still available for volunteers in this experiment?
"Yes, the clinicaltrial.gov website has updated information which shows that this study is still looking for patients to participate. The original posting was on 6/26/2017 and the most recent update was 9/9/2022. There are a total of 399 participants needed from 8 different locations."
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