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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
Be older than 18 years old
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

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 • NCT02018861
63%
Fatigue
50%
Cough
38%
Upper respiratory tract infection
38%
Nausea
25%
Hypertension
25%
Hyperglycaemia
25%
Diarrhoea
25%
Tachycardia
25%
Oral herpes
13%
Hepatic steatosis
13%
Myalgia
13%
Anxiety
13%
Herpes zoster
13%
Neuropathy peripheral
13%
Pyrexia
13%
Radiculopathy
13%
Headache
13%
Paraesthesia
13%
Alanine aminotransferase increased
13%
Bradycardia
13%
Hypokalaemia
13%
Respiratory tract congestion
13%
Acute kidney injury
13%
Hyperlipidaemia
13%
Pain
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 15 mg QD + R-ICE
Parsaclisib 20 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
~280

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
368 Previous Clinical Trials
55,261 Total Patients Enrolled

Media Library

Ibrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04509700 — Phase 2
B-Cell Cancers Research Study Groups: parsaclisib + ibrutinib, parsaclisib + ruxolitinib, parsaclisib, parsaclicib + itacitinib
B-Cell Cancers Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT04509700 — Phase 2
Ibrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04509700 — Phase 2

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
~16 spots leftby Sep 2024