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JAK2 Inhibitor
Pacritinib for Myelofibrosis (PACIFICA Trial)
Phase 3
Recruiting
Research Sponsored by CTI BioPharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TSS of ≥10 on the MPN-SAF TSS 2.0 or a single symptom score of ≥5 or two symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of week 12 to 2 years following week 24 visit
Awards & highlights
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.
Who is the study for?
This trial is for patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis who have severe thrombocytopenia (platelet count <50,000/μL). Participants must be adults with certain risk levels of the disease and able to tolerate MRI or CT scans. They should not have been treated with pacritinib before or other MF therapies recently and must not have significant recent bleeding history or certain heart conditions.Check my eligibility
What is being tested?
The study tests Pacritinib (200 mg twice daily) against Physician's Choice medications in patients with specific types of myelofibrosis and severe low platelet counts. It randomly assigns participants in a 2:1 ratio to either Pacritinib or Physician's Choice therapy, aiming to enroll about 399 patients.See study design
What are the potential side effects?
While the side effects for this trial are not explicitly listed here, common side effects from drugs like Pacritinib may include diarrhea, nausea, vomiting, fatigue, muscle pain. There can also be risks of more serious issues such as liver problems or an increased risk of infections.
PACIFICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience significant pain, itching, or night sweats due to my condition.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My liver and kidney functions are within the required limits.
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I have previously taken JAK2 inhibitor medication.
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I have taken ruxolitinib, but never more than 10 mg per day, and for no longer than 270 days.
Select...
I have taken a JAK2 inhibitor for 90 days or less.
Select...
My condition is classified as Intermediate-1, Intermediate-2, or High risk according to DIPSS.
Select...
My spleen is enlarged and can be felt at least 5 cm below my rib cage.
Select...
I am willing and able to have many MRI or CT scans.
Select...
I have been diagnosed with a type of myelofibrosis.
Select...
I can and will report my symptoms using a provided tool.
PACIFICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of week 12 to 2 years following week 24 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of week 12 to 2 years following week 24 visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Spleen volume
Total Symptom Score (TSS) (excluding tiredness)
Secondary outcome measures
Overall Survival (OS)
Patient Global Impression of Change (PGIC) assessed at Week 24
To compare the safety of pacritinib versus P/C therapy
Other outcome measures
>25% SVR
Best response in SVR
Hemaglobin A1c
+12 moreSide effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160370%
Diarrhea
50%
Febrile neutropenia
50%
Dehydration
50%
Anorexia
40%
Mucositis oral
30%
Nausea
30%
Rash maculo-papular
30%
Hypertension
30%
Fatigue
20%
Neutrophil count decreased
20%
Pain in extremity
20%
Abdominal pain
20%
C Diff
20%
Platelet count decreased
20%
Skin infection
20%
Colitis
20%
Alanine aminotransferase increased
10%
Anaphylaxis
10%
Sinusitis
10%
Oral pain
10%
Metabolism and Nutrition disorders - Other
10%
Edema limbs
10%
Abdominal Pain
10%
Periorbital edema
10%
Pain of skin
10%
Acute GVHD of skin
10%
Edema trunk
10%
Cardiac disorders - Other
10%
Headache -migraine
10%
Vomiting
10%
CMV+
10%
Rectal pain
10%
Aspartate aminotransferase increased
10%
Hyponatremia
10%
Anemia
10%
Creatinine increased
10%
Electrocardiogram QT corrected interval prolonged
10%
Allergic reaction
10%
Soft tissue infection
10%
Metabolism and nutrition disorders - Other
10%
Urticaria
10%
Hypotension
10%
Oral fungus
10%
Headache
10%
Thromboembolic event
10%
Hypoxia
10%
Hallucinations
10%
Anxiety
10%
Insomnia
10%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Phase 2: Pacritinib With Sirolimus and Tacrolimus
PACIFICA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pacritinib 200 mg BIDExperimental Treatment1 Intervention
To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
Group II: Physician's Choice (P/C) therapyActive Control1 Intervention
The Physician's Choice (P/C) therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacritinib
2017
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
CTI BioPharmaLead Sponsor
63 Previous Clinical Trials
4,974 Total Patients Enrolled
8 Trials studying Primary Myelofibrosis
932 Patients Enrolled for Primary Myelofibrosis
PSI CROIndustry Sponsor
6 Previous Clinical Trials
1,859 Total Patients Enrolled
Simran Bedi SinghStudy DirectorCTI BioPharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Physician's Choice (P/C) therapy
- Group 2: Pacritinib 200 mg BID
Awards:
This trial has 2 awards, including:- 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.
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.
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."
Answered by AI
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."
Answered by AI
What conditions does Pacritinib help to treat?
"Pacritinib can be an effective treatment for patients suffering from chemoradiation, dermatitis, atopic conditions, and meningiomas."
Answered by AI
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."
Answered by AI
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