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BTK Inhibitor
Parsaclisib Combinations for B-Cell Cancers
Phase 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol
Has at least stable disease, as determined by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 years
Awards & highlights
Study Summary
This trial is for people who have already been taking parsaclisib in other studies, and will continue to take it either alone or with other drugs.
Who is the study for?
This trial is for people already in Incyte-sponsored parsaclisib studies who are tolerating treatment well, have stable B-cell malignancies, and follow study rules. They must be benefiting from current treatments with parsaclisib alone or combined with itacitinib, ruxolitinib, or ibrutinib and not pregnant nor breastfeeding.Check my eligibility
What is being tested?
The Phase 2 trial provides ongoing access to the drug parsaclisib as a single agent or paired with itacitinib, ruxolitinib, or ibrutinib for participants previously enrolled in related trials. It's an open-label study meaning everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects of parsaclisib include infections due to lowered immunity (participants will take drugs to prevent this), digestive issues, fatigue, liver problems. Side effects may vary when combined with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to follow the study's schedule and treatment plans.
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My condition is stable as confirmed by my doctor.
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I am benefiting from my current cancer treatment involving parsaclisib alone or with other specific drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Side effects data
From 2021 Phase 1 & 2 trial • 88 Patients • NCT0201886163%
Fatigue
50%
Cough
38%
Upper respiratory tract infection
38%
Nausea
25%
Hypertension
25%
Hyperglycaemia
25%
Diarrhoea
25%
Tachycardia
25%
Oral herpes
13%
Alanine aminotransferase increased
13%
Headache
13%
Paraesthesia
13%
Herpes zoster
13%
Hepatic steatosis
13%
Acute kidney injury
13%
Anxiety
13%
Myalgia
13%
Bradycardia
13%
Hypokalaemia
13%
Neuropathy peripheral
13%
Hyperlipidaemia
13%
Pain
13%
Pyrexia
13%
Respiratory tract congestion
13%
Radiculopathy
13%
Neutropenia
13%
Night sweats
13%
Sinusitis
13%
Aspartate aminotransferase increased
13%
Hypophosphataemia
13%
Abdominal distension
13%
Haematuria
13%
Hypotension
13%
Lacrimation increased
13%
Nasal congestion
13%
Neutrophil count decreased
13%
Oedema peripheral
13%
Productive cough
13%
Vertigo
13%
Wound
13%
Abdominal pain
13%
Blood alkaline phosphatase increased
13%
Dyspepsia
13%
Dyspnoea
13%
Malaise
13%
Paranasal sinus discomfort
13%
Renal impairment
13%
Blood creatinine increased
13%
Blood phosphorus increased
13%
Spinal cord compression
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Parsaclisib 20 mg + Itacitinib 300 mg
Total
Parsaclisib 30 mg + Itacitinib 300 mg
Parsaclisib 20 mg QD + R-ICE
Parsaclisib 15 mg QD + R-ICE
Parsaclisib 5 mg QD
Parsaclisib 10 mg QD
Parsaclisib 15 mg QD
Parsaclisib 20 mg QD
Parsaclisib 30 mg QD
Parsaclisib 45 mg QD
Trial Design
4Treatment groups
Experimental Treatment
Group I: parsaclisib + ruxolitinibExperimental Treatment1 Intervention
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.
Group II: parsaclisib + ibrutinibExperimental Treatment1 Intervention
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.
Group III: parsaclisibExperimental Treatment1 Intervention
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.
Group IV: parsaclicib + itacitinibExperimental Treatment1 Intervention
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parsaclisib
2018
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,965 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and treatment plans.I can get parsaclisib alone or with other specific treatments outside a study.You are willing to prevent pregnancy or becoming a father during the study.My condition is stable as confirmed by my doctor.I am benefiting from my current cancer treatment involving parsaclisib alone or with other specific drugs.
Research Study Groups:
This trial has the following groups:- Group 1: parsaclisib + ibrutinib
- Group 2: parsaclisib + ruxolitinib
- Group 3: parsaclisib
- Group 4: parsaclicib + itacitinib
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.
Has the FDA given Parsaclisib its stamp of approval?
"Given the Phase 2 status, our team at Power has evaluated Parsaclisib's safety as a score of 2. Currently, there is some data affirming its security but no studies yet that have proven efficacy."
Answered by AI
How much healthcare infrastructure is being utilized for this research endeavor?
"At the moment, 26 medical facilities are running this clinical trial. Aside from Long Beach, Kansas City and Seattle, there are 23 other sites in various cities across the nation. For ease of access for participants it is encouraged to select a location closest to you."
Answered by AI
Is enrollment for the trial still available to interested participants?
"Affirmative. The clinical trial directory hosted on the governmental website highlights that this research has been open for applications since August 3rd 2020 and is currently in search of 200 participants across 26 facilities."
Answered by AI
What is the current capacity for participants in this medical study?
"To meet the demands of this trial, 200 qualifying patients must be recruited. Incyte Corporation will be handling operations from two locations: Innovative Clinical Research Institute in Long Beach, California and Saint Luke'S Hospital of Kansas City in Missouri."
Answered by AI
What evidence exists of Parsaclisib being examined in other scientific experiments?
"Currently, there are 39 ongoing clinical trials focused on Parsaclisib; four of them in their final stage. These studies have been established mainly in Rozzano but also span 1280 other locations worldwide."
Answered by AI
Has this type of experiment been conducted previously or is it a pioneering endeavor?
"Presently, 39 research trials involving Parsaclisib are underway across 137 cities and 28 states. This drug was initially tested in 2013, when Incyte Corporation sponsored a trial with 121 participants that completed Phase 1 of the approval process. Since then, 20 separate studies have been carried out."
Answered by AI
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