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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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    3 Arizona Oncology Associates, PC - HAL Tempe Arizona United States 85284
    4 Sutter Gould Medical Foundation Modesto California United States 95355
    5 Sharp Memorial Hospital San Diego California United States 92123
    6 Advanced Pharma CR, LLC Miami Florida United States 33147
    7 Asclepes Research Centers Weeki Wachee Florida United States 34607
    8 Advocate Medical Group Niles Milwaukee Ave Niles Illinois United States 60714
    9 Indiana BMT Beech Grove Indiana United States 46107
    10 Parkview Research Center Fort Wayne Indiana United States 46845
    11 University of Kentucky Hospital Lexington Kentucky United States 40536-0298
    12 St. Agnes Hospital Baltimore Maryland United States 21229
    13 Karmanos Cancer Institute Detroit Michigan United States 48201
    14 St. John Hospital and Medical Center Detroit Michigan United States 48236
    15 CHI Health - St. Francis Medical Center Grand Island Nebraska United States 68802
    16 Summit Medical Group Morristown New Jersey United States 07960
    17 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901-1914
    18 Clinical Research Alliance Lake Success New York United States 11042
    19 Abington Memorial Hospital Abington Pennsylvania United States 19001
    20 Utah Cancer Specialists- Network Salt Lake City Utah United States 84106
    21 St Vincent's Hospital Sydney Darlinghurst New South Wales Australia 2010
    22 Westmead Hospital Westmead New South Wales Australia 2145
    23 Flinders Medical Centre Bedford Park South Australia Australia 5042
    24 Ballarat Base Hospital Ballarat Victoria Australia 3350
    25 Sunshine Hospital St Albans Victoria Australia 3021
    26 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    27 ZNA Stuivenberg Antwerpen Belgium 2060
    28 Cliniques Universitaires Ucl Saint-Luc Brussels Belgium 1200
    29 UZ Leuven Leuven Belgium 3000
    30 AZ Delta Roeselare Belgium 8800
    31 LHSC - Victoria Hospital London Ontario Canada N6A 5W9
    32 Fakultni nemocnice Brno Brno Czechia 625 00
    33 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    34 University Hospital Ostrava Ostrava Czechia 70852
    35 Fakultni nemocnice v Motole Praha 5 Czechia 15000
    36 Centre Antoine Lacassagne Nice cedex 02 Alpes Maritimes France 06189
    37 Centre Francois Baclesse Caen Cedex 05 Calvados France 14076
    38 CHU Dijon - Hopital du Bocage Dijon cedex Cote dÝOr France 21079
    39 Centre Hospitalier Libourne Libourne Cedex Gironde France 33505
    40 CHU de Grenoble - Hôpital Albert Michallon Grenoble Isere France 38043
    41 Centre Hospitalier d'Angers Angers Cedex 01 Maine Et Loire France 49033
    42 Hopital Claude Huriez - CHU Lille Lille cedex Nord France 59037
    43 Hôpital Saint-Louis Paris cedex 10 Paris France 75475
    44 Clinique Victor Hugo - Centre Jean Bernard Le Mans Cedex 02 Sarthe France 72015
    45 Hôpital Henri Mondor Créteil Cedex Val De Marne France 94010
    46 Chu de Grenoble - Hopital Albert Michallon Grenoble France 38043
    47 Groupe Hospitalier Pitie-Salpetriere Paris France 75013
    48 Chu Vandoeuvre-Les-Nancy Hopital Brabois Vandoeuvre-les-nancy France 54500
    49 Institut Gustave Roussy Villejuif Cedex France 94805
    50 IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia Italy 71013
    51 Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari Italy 70124
    52 Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Meldola Italy 47014
    53 Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore Rome Italy 00168
    54 Seoul National University Hospital Seoul Korea, Republic of 03080
    55 Severance Hospital, Yonsei University Seoul Korea, Republic of 03722
    56 Asan Medical Center Seoul Korea, Republic of 05505
    57 Samsung Medical Center Seoul Korea, Republic of 06351
    58 Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozów Poland 36-200
    59 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    60 Malopolskie Centrum Medyczne s.c. Krakow Poland 30-510
    61 ICO l´Hospitalet - Hospital Duran i Reynals L'Hospitalet de llobregat Barcelona Spain 08907
    62 Hospital del Mar Barcelona Spain 08003
    63 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    64 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    65 Clinica Universidad de Navarra (Cun) Pamplona Spain 31008
    66 Hospital Universitario Nuestra Señora de Valme Sevilla Spain 41014
    67 Hospital Txagorritxu Vitoria Spain 01009
    68 The Christie Manchester Greater Manchester United Kingdom M20 4BX
    69 Southend University Hospital Southend-on-sea United Kingdom SS0 ORY
    70 Royal Marsden Hospital Sutton United Kingdom SM2 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
    Diffuse large B-cell lymphoma
    relapsed
    refractory
    non-Hodgkin lymphoma
    phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor
    Bruton's tyrosine kinase (BTK)
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    Participant Flow

    Recruitment Details A Phase 2, multicenter, international, open-label study with approximately 120 planned participants with relapsed or refractory DLBCL.
    Pre-assignment Detail 55 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 Title Group A Parsaclisib (no Prior BTK Inhibitor) Group B Parsaclisib (Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib 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
    STARTED 55 5
    COMPLETED 0 0
    NOT COMPLETED 55 5

    Baseline Characteristics

    Arm/Group Title Group A Parsaclisib (no Prior BTK Inhibitor) Group B Parsaclisib (Prior BTK Inhibitor) Total
    Arm/Group Description Parsaclisib 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 Participants 55 5 60
    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
    Title Objective Response Rate Based on Lugano Classification Criteria in Group A
    Description 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.
    Time Frame Every 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 Title Group A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants 55
    Number (95% Confidence Interval) [percentage]
    25.5
    2. Secondary Outcome
    Title Duration of Response in Group A
    Description 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.
    Time Frame Every 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 Title Group A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants 55
    Median (95% Confidence Interval) [months]
    6.2
    3. Secondary Outcome
    Title Progression-free Survival in Group A
    Description 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.
    Time Frame Every 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 Title Group A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants 55
    Median (95% Confidence Interval) [months]
    2.2
    4. Secondary Outcome
    Title Overall Survival (OS) in Group A
    Description Defined as the time from the date of the first dose of study drug until death by any cause.
    Time Frame From 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 Title Group A Parsaclisib (no Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Measure Participants 55
    Median (95% Confidence Interval) [months]
    7.0
    5. Secondary Outcome
    Title Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
    Description 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.
    Time Frame Screening through 35 days after end of treatment, up to 42 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A Parsaclisib (no Prior BTK Inhibitor) Group B Parsaclisib (Prior BTK Inhibitor)
    Arm/Group Description Parsaclisib in subjects who were not previously treated with a BTK inhibitor. Parsaclisib in subjects who were previously treated with a BTK inhibitor.
    Measure Participants 55 5
    Count of Participants [Participants]
    50
    90.9%
    4
    80%

    Adverse Events

    Time Frame Screening through 35 days after end of treatment, up to 42 months
    Adverse Event Reporting Description
    Arm/Group Title Group A Parsaclisib (no Prior BTK Inhibitor) Group B Parsaclisib (Prior BTK Inhibitor) Total
    Arm/Group Description Parsaclisib 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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 45/55 (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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 39/55 (70.9%) 2/5 (40%) 41/60 (68.3%)
    Blood and lymphatic system disorders
    Febrile neutropenia 2/55 (3.6%) 2 0/5 (0%) 0 2/60 (3.3%) 2
    Lymphadenopathy 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Cardiac disorders
    Atrial fibrillation 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Myocardial infarction 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Pericarditis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Ear and labyrinth disorders
    Vertigo positional 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Gastrointestinal disorders
    Abdominal pain 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Colitis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Diarrhoea 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Enterocolitis 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Lower gastrointestinal haemorrhage 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Stomatitis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    General disorders
    Asthenia 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Chest pain 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Fatigue 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    General physical health deterioration 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Multiple organ dysfunction syndrome 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Pyrexia 5/55 (9.1%) 8 0/5 (0%) 0 5/60 (8.3%) 8
    Hepatobiliary disorders
    Jaundice cholestatic 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Infections and infestations
    Lower respiratory tract infection 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Oesophageal candidiasis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Pneumocystis jirovecii pneumonia 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Pneumonia 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Pneumonia bacterial 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Septic shock 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Staphylococcal infection 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Upper respiratory tract infection 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Urinary tract infection 2/55 (3.6%) 2 0/5 (0%) 0 2/60 (3.3%) 2
    Urosepsis 2/55 (3.6%) 2 0/5 (0%) 0 2/60 (3.3%) 2
    Injury, poisoning and procedural complications
    Fall 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Femoral neck fracture 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Subdural haematoma 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Investigations
    Alanine aminotransferase increased 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Aspartate aminotransferase increased 2/55 (3.6%) 2 0/5 (0%) 0 2/60 (3.3%) 2
    Metabolism and nutrition disorders
    Hypercalcaemia 4/55 (7.3%) 4 0/5 (0%) 0 4/60 (6.7%) 4
    Hypokalaemia 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Hyponatraemia 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Mobility decreased 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Prostate cancer metastatic 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Nervous system disorders
    Cerebrovascular accident 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Dizziness 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Presyncope 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Syncope 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Psychiatric disorders
    Confusional state 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Renal and urinary disorders
    Hydronephrosis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Pleural effusion 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 2/55 (3.6%) 2 0/5 (0%) 0 2/60 (3.3%) 2
    Rash pruritic 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Vascular disorders
    Deep vein thrombosis 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (1.7%) 1
    Hypotension 1/55 (1.8%) 3 0/5 (0%) 0 1/60 (1.7%) 3
    Orthostatic hypotension 1/55 (1.8%) 1 0/5 (0%) 0 1/60 (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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 41/55 (74.5%) 3/5 (60%) 44/60 (73.3%)
    Blood and lymphatic system disorders
    Anaemia 4/55 (7.3%) 4 0/5 (0%) 0 4/60 (6.7%) 4
    Gastrointestinal disorders
    Abdominal pain 4/55 (7.3%) 6 0/5 (0%) 0 4/60 (6.7%) 6
    Constipation 5/55 (9.1%) 5 0/5 (0%) 0 5/60 (8.3%) 5
    Diarrhoea 10/55 (18.2%) 11 0/5 (0%) 0 10/60 (16.7%) 11
    Dry mouth 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Haemorrhoids 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Nausea 11/55 (20%) 11 0/5 (0%) 0 11/60 (18.3%) 11
    Vomiting 4/55 (7.3%) 5 0/5 (0%) 0 4/60 (6.7%) 5
    General disorders
    Chills 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Fatigue 4/55 (7.3%) 4 1/5 (20%) 1 5/60 (8.3%) 5
    General physical health deterioration 1/55 (1.8%) 1 1/5 (20%) 1 2/60 (3.3%) 2
    Non-cardiac chest pain 1/55 (1.8%) 1 1/5 (20%) 1 2/60 (3.3%) 2
    Oedema peripheral 4/55 (7.3%) 4 0/5 (0%) 0 4/60 (6.7%) 4
    Pyrexia 5/55 (9.1%) 7 0/5 (0%) 0 5/60 (8.3%) 7
    Infections and infestations
    Bronchopulmonary aspergillosis 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Nasopharyngitis 1/55 (1.8%) 3 1/5 (20%) 1 2/60 (3.3%) 4
    Rhinitis 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Urinary tract infection 4/55 (7.3%) 4 0/5 (0%) 0 4/60 (6.7%) 4
    Injury, poisoning and procedural complications
    Fall 4/55 (7.3%) 4 0/5 (0%) 0 4/60 (6.7%) 4
    Rib fracture 0/55 (0%) 0 2/5 (40%) 2 2/60 (3.3%) 2
    Investigations
    Neutrophil count decreased 5/55 (9.1%) 5 0/5 (0%) 0 5/60 (8.3%) 5
    Weight decreased 3/55 (5.5%) 3 1/5 (20%) 1 4/60 (6.7%) 4
    Metabolism and nutrition disorders
    Decreased appetite 5/55 (9.1%) 5 0/5 (0%) 0 5/60 (8.3%) 5
    Hyperglycaemia 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Hyperkalaemia 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Hypokalaemia 3/55 (5.5%) 4 0/5 (0%) 0 3/60 (5%) 4
    Hypomagnesaemia 3/55 (5.5%) 6 0/5 (0%) 0 3/60 (5%) 6
    Hyponatraemia 3/55 (5.5%) 3 1/5 (20%) 1 4/60 (6.7%) 4
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/55 (5.5%) 3 1/5 (20%) 1 4/60 (6.7%) 4
    Back pain 3/55 (5.5%) 3 1/5 (20%) 1 4/60 (6.7%) 4
    Muscle spasms 1/55 (1.8%) 1 1/5 (20%) 1 2/60 (3.3%) 2
    Pain in extremity 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Polyarthritis 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Tendonitis 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Nervous system disorders
    Balance disorder 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Headache 3/55 (5.5%) 4 0/5 (0%) 0 3/60 (5%) 4
    Polyneuropathy 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Psychiatric disorders
    Anxiety 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Cough 9/55 (16.4%) 10 0/5 (0%) 0 9/60 (15%) 10
    Dyspnoea 7/55 (12.7%) 7 1/5 (20%) 2 8/60 (13.3%) 9
    Pneumothorax 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Skin and subcutaneous tissue disorders
    Erythema 1/55 (1.8%) 1 1/5 (20%) 1 2/60 (3.3%) 2
    Night sweats 0/55 (0%) 0 1/5 (20%) 1 1/60 (1.7%) 1
    Pruritus 3/55 (5.5%) 4 1/5 (20%) 1 4/60 (6.7%) 5
    Rash 2/55 (3.6%) 2 1/5 (20%) 1 3/60 (5%) 3
    Rash erythematous 3/55 (5.5%) 3 0/5 (0%) 0 3/60 (5%) 3
    Urticaria 1/55 (1.8%) 1 1/5 (20%) 1 2/60 (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/Title Study Director
    Organization Incyte Corporation
    Phone 1-855-463-3463
    Email medinfo@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