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Tyrosine Kinase Inhibitor
Pacritinib for Prostate Cancer (BLAST Trial)
Phase 2
Waitlist Available
Led By Deepak Kilari, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estimated glomerular filtration rate (GFR) > 45 ml/min using Cockroft-Gault equation
Histologically or cytologically confirmed prostate adenocarcinoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and four months
Awards & highlights
BLAST Trial Summary
This trial is testing a drug called pacritinib for men with prostate cancer who have already had treatment.
Who is the study for?
Men over 18 with prostate cancer that's come back after surgery or radiation, but without evidence of metastasis. They should have a PSA doubling time of ≤9 months and be willing to use effective contraception. Men who've had JAK2 inhibitors, certain recent treatments for prostate cancer, or uncontrolled health conditions are excluded.Check my eligibility
What is being tested?
The trial is testing Pacritinib in men with biochemical recurrence of prostate adenocarcinoma post definitive treatment. It's an open-label study meaning everyone knows they're getting the drug, and it includes providing blood and tissue samples for research.See study design
What are the potential side effects?
Specific side effects aren't listed here, but generally, drugs like Pacritinib can cause issues like high blood pressure, liver problems, bleeding risks, gastrointestinal disturbances or could affect heart rhythm.
BLAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by GFR, is above 45 ml/min.
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My prostate cancer was confirmed through a tissue test.
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I have had surgery or radiation for prostate cancer.
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I have never been treated with JAK2 inhibitors.
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I am 18 years old or older.
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I am a male and agree to use effective contraception during and for 60 days after the study.
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My prostate cancer was confirmed through a tissue test.
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My liver tests are within normal limits.
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My hemoglobin level is at least 9.0 g/dL without needing transfusions or growth factors in the last 3 months.
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I have had surgery or radiation for prostate cancer.
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I am fully active or able to carry out light work.
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My prostate cancer has returned, and my PSA levels are rising quickly.
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My prostate cancer has returned, and my PSA levels are doubling in 9 months or less.
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I have never been treated with JAK2 inhibitors.
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I am fully active or able to carry out light work.
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My heart pumps well, with an ejection fraction of 50% or higher.
Select...
I am 18 years old or older.
BLAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of patients with six-month PSA progression-free survival.
Secondary outcome measures
PSA Levels
Testosterone Measurement
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160345%
Febrile neutropenia
41%
Mucositis oral
36%
Platelet count decreased
23%
Diarrhea
23%
Neutrophil count decreased
23%
Rash maculo-papular
18%
Anemia
18%
Hypertension
18%
Fatigue
14%
Headache
14%
Acute kidney injury
14%
Dehydration
9%
Alanine aminotransferase increased
9%
Anorexia
9%
Aspartate aminotransferase increased
9%
Hypotension
9%
Cellulitis
5%
Diffuse rash on face, trunk, and extremities; eyelids swelling
5%
Dyspnea
5%
Respiratory failure
5%
Lung infection
5%
C Diff
5%
Fracture
5%
Multi-organ failure
5%
Infusion related reaction
5%
Folicular rash
5%
Tremors
5%
Delirium
5%
Fever
5%
Erythroderma -acute GVHD
5%
Sinusitis
5%
Rash over body
5%
Lung infection -Pneumonia
5%
Sepsis
5%
Suspected VOD
5%
Abdominal distension
5%
Respiratory Failure
5%
Urinary tract pain
5%
Fall
5%
CPK increased
5%
Skin sloughing off
5%
Chills
5%
Encephalopathy
5%
Myocardial infarction
5%
Mulit-organ failure
5%
Nausea
5%
Tachycardia
5%
Encephalitis - HHV6
5%
Electrocardiogram QT corrected interval prolonged
5%
Catheter related infection
5%
Bilirubin increase
5%
Dry mouth
5%
Creatinine increased
5%
White blood cell count decreased
5%
Abdominal Pain
5%
LDH Increased
5%
Alanine aminotransferase increased - VOD
5%
Alanine aminotransferase increased - suspected VOD
5%
Hypokalemia
5%
Erythroderma
5%
Pulmonary edema
5%
Hyponatremia
5%
Hypophosphatemia
5%
Meningitis
5%
Insomnia
5%
Epistaxis
5%
Lethargy
5%
Gastrointestinal Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
BLAST Trial Design
1Treatment groups
Experimental Treatment
Group I: PacritinibExperimental Treatment1 Intervention
Pacritinib is an oral drug.
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?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,707 Total Patients Enrolled
7 Trials studying Prostate Cancer
8,433 Patients Enrolled for Prostate Cancer
Deepak Kilari, MDPrincipal Investigator - Medical College of Wisconsin
Clement J. Zablocki VA Medical Center, Froedtert & The Medical College of Wisconsin
2 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Prostate Cancer
42 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by GFR, is above 45 ml/min.I haven't taken any 5-alpha reductase inhibitors in the last 42 days.My liver is not working well (severe issues).My scans show no clear signs of cancer spread, except possibly small lymph nodes or uncertain bone lesions.My prostate cancer was confirmed through a tissue test.I do not have a prolonged QT interval (>450 ms) or conditions like heart failure.I've had hormone therapy for prostate cancer more than 9 months ago, lasting no more than 3 years.My scans show no clear signs of cancer spread, except possibly small lymph nodes or uncertain bone lesions.I have had surgery or radiation for prostate cancer.I have been treated with pacritinib before.My blood tests show my organs are working well.I have never been treated with JAK2 inhibitors.I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days.I have had radiation before or cannot have it due to my health and cancer type.I haven't had serious bleeding issues in the last 3 months.I haven't taken any prohibited medications in the last week.I do not have an active hepatitis A, B, or C infection.I have had chemotherapy for prostate cancer less than 6 months ago, but only as part of initial treatment.I take more than 10 mg of prednisone or equivalent daily for a chronic condition.My heart condition limits my physical activity.I am 18 years old or older.I am a male and agree to use effective contraception during and for 60 days after the study.My prostate cancer was confirmed through a tissue test.My liver tests are within normal limits.My blood potassium level is at least 3.5 mmol/L.My hemoglobin level is at least 9.0 g/dL without needing transfusions or growth factors in the last 3 months.I have had surgery or radiation for prostate cancer.I am fully active or able to carry out light work.I haven't had any cancer other than certain skin, cervical, or in situ breast cancers in the last 3 years.I haven't taken any blood-thinning or certain anti-inflammatory drugs in the last 14 days.My prostate cancer has returned, and my PSA levels are rising quickly.I've had radiation before or can't have it due to my health and cancer type.I haven't taken any medications that affect heart rhythm timing in the last 14 days.My prostate cancer has returned, and my PSA levels are doubling in 9 months or less.I have never been treated with JAK2 inhibitors.You are willing to give blood and tissue samples for research purposes, but it's not required to be in the trial.I am fully active or able to carry out light work.My heart pumps well, with an ejection fraction of 50% or higher.I am 18 years old or older.I have had surgery to remove both testicles.My blood pressure is not controlled by medication.I do not have stomach or metabolic issues affecting medication absorption.I have an active or uncontrolled bowel disorder like Crohn's disease.I have been treated with specific hormone therapies for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Pacritinib
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.
What other analyses have been conducted in relation to Pacritinib?
"Currently, 6 trials are running for Pacritinib. Out of those investigations, 1 is in its third and final phase. While the majority of these clinical studies take place around Tampa, Florida; 172 other medical sites have been enlisted to host research into this treatment option."
Answered by AI
Does this research mark a precedent in its field?
"Presently, 48 cities across 22 nations are hosting 6 active clinical trials for Pacritinib. The initial trial of this drug was administered by CTI BioPharma in 2017 with 43 patients and went through the phase 1 & 2 approval process. Subsequently, 11 more studies have been completed since then."
Answered by AI
What is the current patient quota for this research endeavor?
"Affirmative. The clinicaltrial.gov website has verified that this trial is actively enrolling participants, which began recruitment on June 1st 2021 and was last updated July 18th 2022. 46 volunteers are needed for the single study location."
Answered by AI
What adverse effects might individuals experience from taking Pacritinib?
"Pacritinib's safety was assigned a rating of 2 due to its Phase 2 trial status, that is, there exists evidence supporting pacritinib's security yet no clinical data for efficacy."
Answered by AI
Is this exploration actively seeking out participants?
"According to the clinicaltrials.gov website, this research endeavour is presently recruiting volunteers; it was first advertised on June 1st 2021 and has been recently modified as of July 18th 2022."
Answered by AI
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