A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02998476
Collaborator
(none)
60
Enrollment
70
Locations
2
Arms
47.2
Actual Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Actual Study Start Date :
Mar 2, 2017
Actual Primary Completion Date :
Feb 22, 2019
Actual Study Completion Date :
Feb 5, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A Parsaclisib (no prior BTK inhibitor)

Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Names:
  • INCB050465
  • Experimental: Group B Parsaclisib (prior BTK inhibitor)

    Parsaclisib in subjects who were previously treated with a BTK inhibitor.

    Drug: Parsaclisib
    Parsaclisib once daily for 8 weeks followed by once weekly
    Other Names:
  • INCB050465
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate Based on Lugano Classification Criteria in Group A [Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months]

      Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.

    Secondary Outcome Measures

    1. Duration of Response in Group A [Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months]

      Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.

    2. Progression-free Survival in Group A [Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months]

      Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.

    3. Overall Survival (OS) in Group A [From first dose of study drug until death by any cause; up to 26 months]

      Defined as the time from the date of the first dose of study drug until death by any cause.

    4. Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B [Screening through 35 days after end of treatment, up to 42 months]

      A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eligible 19 years and older in South Korea

    • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.

    • Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).

    • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.

    • Eastern Cooperative Oncology Group performance status 0 to 2.

    Exclusion Criteria:
    • Primary mediastinal (thymic) large B-cell lymphoma.

    • Known brain or central nervous system metastases or history of uncontrolled seizures.

    • Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.

    • Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.

    • Prior treatment with the following:

    • Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).

    • Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35233
    2Banner MD Anderson Cancer CenterGilbertArizonaUnited States85234
    3Arizona Oncology Associates, PC - HALTempeArizonaUnited States85284
    4Sutter Gould Medical FoundationModestoCaliforniaUnited States95355
    5Sharp Memorial HospitalSan DiegoCaliforniaUnited States92123
    6Advanced Pharma CR, LLCMiamiFloridaUnited States33147
    7Asclepes Research CentersWeeki WacheeFloridaUnited States34607
    8Advocate Medical Group Niles Milwaukee AveNilesIllinoisUnited States60714
    9Indiana BMTBeech GroveIndianaUnited States46107
    10Parkview Research CenterFort WayneIndianaUnited States46845
    11University of Kentucky HospitalLexingtonKentuckyUnited States40536-0298
    12St. Agnes HospitalBaltimoreMarylandUnited States21229
    13Karmanos Cancer InstituteDetroitMichiganUnited States48201
    14St. John Hospital and Medical CenterDetroitMichiganUnited States48236
    15CHI Health - St. Francis Medical CenterGrand IslandNebraskaUnited States68802
    16Summit Medical GroupMorristownNew JerseyUnited States07960
    17Rutgers Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States08901-1914
    18Clinical Research AllianceLake SuccessNew YorkUnited States11042
    19Abington Memorial HospitalAbingtonPennsylvaniaUnited States19001
    20Utah Cancer Specialists- NetworkSalt Lake CityUtahUnited States84106
    21St Vincent's Hospital SydneyDarlinghurstNew South WalesAustralia2010
    22Westmead HospitalWestmeadNew South WalesAustralia2145
    23Flinders Medical CentreBedford ParkSouth AustraliaAustralia5042
    24Ballarat Base HospitalBallaratVictoriaAustralia3350
    25Sunshine HospitalSt AlbansVictoriaAustralia3021
    26Fiona Stanley HospitalMurdochWestern AustraliaAustralia6150
    27ZNA StuivenbergAntwerpenBelgium2060
    28Cliniques Universitaires Ucl Saint-LucBrusselsBelgium1200
    29UZ LeuvenLeuvenBelgium3000
    30AZ DeltaRoeselareBelgium8800
    31LHSC - Victoria HospitalLondonOntarioCanadaN6A 5W9
    32Fakultni nemocnice BrnoBrnoCzechia625 00
    33Fakultni nemocnice Hradec KraloveHradec KraloveCzechia500 05
    34University Hospital OstravaOstravaCzechia70852
    35Fakultni nemocnice v MotolePraha 5Czechia15000
    36Centre Antoine LacassagneNice cedex 02Alpes MaritimesFrance06189
    37Centre Francois BaclesseCaen Cedex 05CalvadosFrance14076
    38CHU Dijon - Hopital du BocageDijon cedexCote dÝOrFrance21079
    39Centre Hospitalier LibourneLibourne CedexGirondeFrance33505
    40CHU de Grenoble - Hôpital Albert MichallonGrenobleIsereFrance38043
    41Centre Hospitalier d'AngersAngers Cedex 01Maine Et LoireFrance49033
    42Hopital Claude Huriez - CHU LilleLille cedexNordFrance59037
    43Hôpital Saint-LouisParis cedex 10ParisFrance75475
    44Clinique Victor Hugo - Centre Jean BernardLe Mans Cedex 02SartheFrance72015
    45Hôpital Henri MondorCréteil CedexVal De MarneFrance94010
    46Chu de Grenoble - Hopital Albert MichallonGrenobleFrance38043
    47Groupe Hospitalier Pitie-SalpetriereParisFrance75013
    48Chu Vandoeuvre-Les-Nancy Hopital BraboisVandoeuvre-les-nancyFrance54500
    49Institut Gustave RoussyVillejuif CedexFrance94805
    50IRCCS Ospedale Casa Sollievo della SofferenzaSan Giovanni RotondoFoggiaItaly71013
    51Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico BariBariItaly70124
    52Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei TumoriMeldolaItaly47014
    53Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro CuoreRomeItaly00168
    54Seoul National University HospitalSeoulKorea, Republic of03080
    55Severance Hospital, Yonsei UniversitySeoulKorea, Republic of03722
    56Asan Medical CenterSeoulKorea, Republic of05505
    57Samsung Medical CenterSeoulKorea, Republic of06351
    58Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.MarkiewiczaBrzozówPoland36-200
    59Uniwersyteckie Centrum KliniczneGdanskPoland80-952
    60Malopolskie Centrum Medyczne s.c.KrakowPoland30-510
    61ICO l´Hospitalet - Hospital Duran i ReynalsL'Hospitalet de llobregatBarcelonaSpain08907
    62Hospital del MarBarcelonaSpain08003
    63Hospital General Universitario Gregorio MarañonMadridSpain28007
    64Hospital Universitario Ramon y CajalMadridSpain28034
    65Clinica Universidad de Navarra (Cun)PamplonaSpain31008
    66Hospital Universitario Nuestra Señora de ValmeSevillaSpain41014
    67Hospital TxagorritxuVitoriaSpain01009
    68The ChristieManchesterGreater ManchesterUnited KingdomM20 4BX
    69Southend University HospitalSouthend-on-seaUnited KingdomSS0 ORY
    70Royal Marsden HospitalSuttonUnited KingdomSM2 5PT

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Claudia Corrado, MD, Incyte Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02998476
    Other Study ID Numbers:
    • INCB 50465-202/CITADEL-202
    • Parsaclisib
    First Posted:
    Dec 20, 2016
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsA Phase 2, multicenter, international, open-label study with approximately 120 planned participants with relapsed or refractory DLBCL.
    Pre-assignment Detail55 participants included in the treatment group A who were not previously treated with a BTK inhibitor and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW. 5 Participants were enrolled in group B who were previously treated with a BTK inhibitor. and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW.
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.Parsaclisib in subjects who were previously treated with a BTK inhibitor.
    Period Title: Overall Study
    STARTED555
    COMPLETED00
    NOT COMPLETED555

    Baseline Characteristics

    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)Total
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.Parsaclisib in subjects who were previously treated with a BTK inhibitor.Total of all reporting groups
    Overall Participants55560
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69.6
    (12.62)
    68.4
    (12.97)
    69.5
    (12.54)
    Sex: Female, Male (Count of Participants)
    Female
    22
    40%
    0
    0%
    22
    36.7%
    Male
    33
    60%
    5
    100%
    38
    63.3%
    Race/Ethnicity, Customized (Count of Participants)
    White/Caucasian
    42
    76.4%
    5
    100%
    47
    78.3%
    Black or African American
    2
    3.6%
    0
    0%
    2
    3.3%
    Asian
    3
    5.5%
    0
    0%
    3
    5%
    Other
    6
    10.9%
    0
    0%
    6
    10%
    Missing
    2
    3.6%
    0
    0%
    2
    3.3%
    Race/Ethnicity, Customized (Count of Participants)
    Not Hispanic or Latino
    37
    67.3%
    5
    100%
    42
    70%
    Not Reported
    10
    18.2%
    0
    0%
    10
    16.7%
    Unknown
    7
    12.7%
    0
    0%
    7
    11.7%
    Missing
    1
    1.8%
    0
    0%
    1
    1.7%
    ECOG (Count of Participants)
    0
    12
    21.8%
    1
    20%
    13
    21.7%
    1
    34
    61.8%
    3
    60%
    37
    61.7%
    2
    9
    16.4%
    1
    20%
    10
    16.7%

    Outcome Measures

    1. Primary Outcome
    TitleObjective Response Rate Based on Lugano Classification Criteria in Group A
    DescriptionDefined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
    Time FrameEvery 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

    Outcome Measure Data

    Analysis Population Description
    The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants55
    Number (95% Confidence Interval) [percentage]
    25.5
    2. Secondary Outcome
    TitleDuration of Response in Group A
    DescriptionDefined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
    Time FrameEvery 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

    Outcome Measure Data

    Analysis Population Description
    The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants55
    Median (95% Confidence Interval) [months]
    6.2
    3. Secondary Outcome
    TitleProgression-free Survival in Group A
    DescriptionDefined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
    Time FrameEvery 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months

    Outcome Measure Data

    Analysis Population Description
    The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants55
    Median (95% Confidence Interval) [months]
    2.2
    4. Secondary Outcome
    TitleOverall Survival (OS) in Group A
    DescriptionDefined as the time from the date of the first dose of study drug until death by any cause.
    Time FrameFrom first dose of study drug until death by any cause; up to 26 months

    Outcome Measure Data

    Analysis Population Description
    The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants55
    Median (95% Confidence Interval) [months]
    7.0
    5. Secondary Outcome
    TitleSafety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
    DescriptionA TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
    Time FrameScreening through 35 days after end of treatment, up to 42 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.Parsaclisib in subjects who were previously treated with a BTK inhibitor.
    Measure Participants555
    Count of Participants [Participants]
    50
    90.9%
    4
    80%

    Adverse Events

    Time FrameScreening through 35 days after end of treatment, up to 42 months
    Adverse Event Reporting Description
    Arm/Group TitleGroup A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)Total
    Arm/Group DescriptionParsaclisib in subjects who were not previously treated with a BTK inhibitor.Parsaclisib in subjects who were previously treated with a BTK inhibitor.Total
    All Cause Mortality
    Group A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)Total
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total45/55 (81.8%) 3/5 (60%) 48/60 (80%)
    Serious Adverse Events
    Group A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)Total
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total39/55 (70.9%) 2/5 (40%) 41/60 (68.3%)
    Blood and lymphatic system disorders
    Febrile neutropenia2/55 (3.6%) 20/5 (0%) 02/60 (3.3%) 2
    Lymphadenopathy1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Cardiac disorders
    Atrial fibrillation1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Myocardial infarction1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Pericarditis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Ear and labyrinth disorders
    Vertigo positional1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Gastrointestinal disorders
    Abdominal pain3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Colitis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Diarrhoea1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Enterocolitis0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Lower gastrointestinal haemorrhage1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Stomatitis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    General disorders
    Asthenia1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Chest pain1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Fatigue1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    General physical health deterioration3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Multiple organ dysfunction syndrome1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Pyrexia5/55 (9.1%) 80/5 (0%) 05/60 (8.3%) 8
    Hepatobiliary disorders
    Jaundice cholestatic1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Infections and infestations
    Lower respiratory tract infection1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Oesophageal candidiasis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Pneumocystis jirovecii pneumonia0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Pneumonia1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Pneumonia bacterial1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Septic shock1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Staphylococcal infection0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Upper respiratory tract infection1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Urinary tract infection2/55 (3.6%) 20/5 (0%) 02/60 (3.3%) 2
    Urosepsis2/55 (3.6%) 20/5 (0%) 02/60 (3.3%) 2
    Injury, poisoning and procedural complications
    Fall1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Femoral neck fracture1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Subdural haematoma1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Investigations
    Alanine aminotransferase increased1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Aspartate aminotransferase increased2/55 (3.6%) 20/5 (0%) 02/60 (3.3%) 2
    Metabolism and nutrition disorders
    Hypercalcaemia4/55 (7.3%) 40/5 (0%) 04/60 (6.7%) 4
    Hypokalaemia1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Hyponatraemia1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Musculoskeletal and connective tissue disorders
    Back pain1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Mobility decreased1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Prostate cancer metastatic1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Nervous system disorders
    Cerebrovascular accident1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Dizziness1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Presyncope1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Syncope1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Psychiatric disorders
    Confusional state1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Renal and urinary disorders
    Hydronephrosis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Pleural effusion1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular2/55 (3.6%) 20/5 (0%) 02/60 (3.3%) 2
    Rash pruritic1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Vascular disorders
    Deep vein thrombosis1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Hypotension1/55 (1.8%) 30/5 (0%) 01/60 (1.7%) 3
    Orthostatic hypotension1/55 (1.8%) 10/5 (0%) 01/60 (1.7%) 1
    Other (Not Including Serious) Adverse Events
    Group A Parsaclisib (no Prior BTK Inhibitor)Group B Parsaclisib (Prior BTK Inhibitor)Total
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total41/55 (74.5%) 3/5 (60%) 44/60 (73.3%)
    Blood and lymphatic system disorders
    Anaemia4/55 (7.3%) 40/5 (0%) 04/60 (6.7%) 4
    Gastrointestinal disorders
    Abdominal pain4/55 (7.3%) 60/5 (0%) 04/60 (6.7%) 6
    Constipation5/55 (9.1%) 50/5 (0%) 05/60 (8.3%) 5
    Diarrhoea10/55 (18.2%) 110/5 (0%) 010/60 (16.7%) 11
    Dry mouth3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Haemorrhoids0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Nausea11/55 (20%) 110/5 (0%) 011/60 (18.3%) 11
    Vomiting4/55 (7.3%) 50/5 (0%) 04/60 (6.7%) 5
    General disorders
    Chills3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Fatigue4/55 (7.3%) 41/5 (20%) 15/60 (8.3%) 5
    General physical health deterioration1/55 (1.8%) 11/5 (20%) 12/60 (3.3%) 2
    Non-cardiac chest pain1/55 (1.8%) 11/5 (20%) 12/60 (3.3%) 2
    Oedema peripheral4/55 (7.3%) 40/5 (0%) 04/60 (6.7%) 4
    Pyrexia5/55 (9.1%) 70/5 (0%) 05/60 (8.3%) 7
    Infections and infestations
    Bronchopulmonary aspergillosis0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Nasopharyngitis1/55 (1.8%) 31/5 (20%) 12/60 (3.3%) 4
    Rhinitis0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Urinary tract infection4/55 (7.3%) 40/5 (0%) 04/60 (6.7%) 4
    Injury, poisoning and procedural complications
    Fall4/55 (7.3%) 40/5 (0%) 04/60 (6.7%) 4
    Rib fracture0/55 (0%) 02/5 (40%) 22/60 (3.3%) 2
    Investigations
    Neutrophil count decreased5/55 (9.1%) 50/5 (0%) 05/60 (8.3%) 5
    Weight decreased3/55 (5.5%) 31/5 (20%) 14/60 (6.7%) 4
    Metabolism and nutrition disorders
    Decreased appetite5/55 (9.1%) 50/5 (0%) 05/60 (8.3%) 5
    Hyperglycaemia3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Hyperkalaemia0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Hypokalaemia3/55 (5.5%) 40/5 (0%) 03/60 (5%) 4
    Hypomagnesaemia3/55 (5.5%) 60/5 (0%) 03/60 (5%) 6
    Hyponatraemia3/55 (5.5%) 31/5 (20%) 14/60 (6.7%) 4
    Musculoskeletal and connective tissue disorders
    Arthralgia3/55 (5.5%) 31/5 (20%) 14/60 (6.7%) 4
    Back pain3/55 (5.5%) 31/5 (20%) 14/60 (6.7%) 4
    Muscle spasms1/55 (1.8%) 11/5 (20%) 12/60 (3.3%) 2
    Pain in extremity3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Polyarthritis0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Tendonitis0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Nervous system disorders
    Balance disorder0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Headache3/55 (5.5%) 40/5 (0%) 03/60 (5%) 4
    Polyneuropathy0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Psychiatric disorders
    Anxiety3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Respiratory, thoracic and mediastinal disorders
    Asthma0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Cough9/55 (16.4%) 100/5 (0%) 09/60 (15%) 10
    Dyspnoea7/55 (12.7%) 71/5 (20%) 28/60 (13.3%) 9
    Pneumothorax0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Skin and subcutaneous tissue disorders
    Erythema1/55 (1.8%) 11/5 (20%) 12/60 (3.3%) 2
    Night sweats0/55 (0%) 01/5 (20%) 11/60 (1.7%) 1
    Pruritus3/55 (5.5%) 41/5 (20%) 14/60 (6.7%) 5
    Rash2/55 (3.6%) 21/5 (20%) 13/60 (5%) 3
    Rash erythematous3/55 (5.5%) 30/5 (0%) 03/60 (5%) 3
    Urticaria1/55 (1.8%) 11/5 (20%) 12/60 (3.3%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Clinical Study Agreement

    Results Point of Contact

    Name/TitleStudy Director
    OrganizationIncyte Corporation
    Phone1-855-463-3463
    Emailmedinfo@incyte.com
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02998476
    Other Study ID Numbers:
    • INCB 50465-202/CITADEL-202
    • Parsaclisib
    First Posted:
    Dec 20, 2016
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Feb 1, 2022