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PI3K Inhibitor

parsaclisib for Cancer

Phase 1
Waitlist Available
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 4 days for period 1 and 2
Awards & highlights

Study Summary

This study is evaluating whether a drug may be safe and effective for treating cancer.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days for period 1 and 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for period 1 and 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib
Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib
Pharmacokinetics Parameter Group 5: Cmax of parsaclisib
+3 more
Secondary outcome measures
Number of Treatment Emergent Adverse Events (TEAE) Group 5
Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4
Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib
+8 more

Side effects data

From 2023 Phase 2 trial • 42 Patients • NCT04434937
26%
Diarrhoea
19%
Neutrophil count decreased
19%
Stomatitis
17%
Constipation
12%
Cytomegalovirus infection reactivation
12%
Neutropenia
12%
Arthralgia
10%
Decreased appetite
10%
Aspartate aminotransferase increased
10%
Hypokalaemia
10%
Hypertension
10%
Back pain
10%
Herpes zoster
10%
Eczema
10%
Alanine aminotransferase increased
10%
Nausea
7%
Dry skin
7%
Conjunctivitis
7%
Dehydration
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypogammaglobulinaemia
5%
COVID-19
5%
Cytomegalovirus colitis
2%
Hepatic function abnormal
2%
Immune-mediated enterocolitis
2%
Arthritis
2%
Cardiac failure
2%
Cytomegalovirus enteritis
2%
Tumour pain
2%
Urethritis
2%
Atrial fibrillation
2%
Cataract
2%
Aortic aneurysm
2%
Febrile neutropenia
2%
Cheilitis
2%
Myocardial infarction
2%
Fracture
2%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Parsaclisib 20 mg/2.5 mg
Total

Trial Design

5Treatment groups
Experimental Treatment
Group I: Treat Group 5 : Kidney FailureExperimental Treatment1 Intervention
eGFR: < 15 mL/min/1.73 m^2 on Hemo Dialysis
Group II: Treat Group 4 : Severe Renal ImpairmentExperimental Treatment1 Intervention
eGFR: 15-29 mL/min/1.73 m^2 and not on Hemo Dialysis
Group III: Treat Group 3 : Moderate Renal ImpairmentExperimental Treatment1 Intervention
eGFR: 30-59 mL/min/1.73 m^2
Group IV: Treat Group 2 : Mild Renal ImpairmentExperimental Treatment1 Intervention
eGFR: 60-89 mL/min/1.73 m^2
Group V: Treat Group 1 : Normal Renal FunctionExperimental Treatment1 Intervention
eGFR: ≥ 90 mL/min/1.73 m^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
parsaclisib
2021
Completed Phase 2
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
2021. "To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04831996.
~12 spots leftby Apr 2025
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