A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Parsaclisib (INCB050465)

2022-501687-18-00 Protocol INCB 50465-801 Therapeutic exploratory (Phase II) Authorised, recruiting

Start 28 Oct 2020 · Status Authorised, recruiting · 8 EU/EEA countries · 33 sites · Protocol INCB 50465-801

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruiting
Participants planned 200
Countries 8
Sites 33

Advanced malignancies and IAI diseases

To provide continued treatment and evaluation of safety in participants receiving parsaclisib (INCB050465) as monotherapy or in combination therapy with itacitinib (INCB039110), ruxolitinib (INCB018424), or ibrutinib., or tafasitamab (INCMOR00208; including participants who remain on tafasitamab alone).

Key facts

Sponsor
Incyte Corp.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20], Diseases [C] - Neoplasms [C04]
Trial duration
28 Oct 2020 → ongoing
Decision date (initial)
2023-01-31
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

External identifiers

EU CT number
2022-501687-18-00
EudraCT number
2019-004948-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

To provide continued treatment and evaluation of safety in participants receiving parsaclisib (INCB050465) as monotherapy or in combination therapy with itacitinib (INCB039110), ruxolitinib (INCB018424), or ibrutinib., or tafasitamab (INCMOR00208; including participants who remain on tafasitamab alone).

Conditions and MedDRA coding

Advanced malignancies and IAI diseases

VersionLevelCodeTermSystem organ class
21.0 LLT 10048683 Advanced cancer 10029104
20.0 LLT 10003825 Autoimmune hemolytic anemia 10005329

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
  2. Currently tolerating treatment in the parent Protocol.
  3. Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone) as determined by the investigator.
  4. Has at least stable disease, as determined by the investigator.
  5. Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
  6. Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
  7. Willingness to avoid pregnancy or fathering children based on the criteria described in Protocol section 5.1
  8. Ability to comprehend and willingness to sign an ICF.

Exclusion criteria 4

  1. Has been permanently discontinued from study treatment in the parent Protocol for any reason.
  2. Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including tafasitamab alone) outside a clinical study.
  3. Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
  4. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. To assess AEs and SAEs reported in participants receiving parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

IMBRUVICA 140 mg hard capsules

PRD1729393 · Product

Active substance
Ibrutinib
Substance synonyms
1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
560 mg milligram(s)
Max total dose
560 mg milligram(s)
Max treatment duration
22 Week(s)
Authorisation status
Authorised
ATC code
L01EL01 — -
Marketing authorisation
EU/1/14/945/002
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

IMBRUVICA 140 mg hard capsules

PRD1729387 · Product

Active substance
Ibrutinib
Substance synonyms
1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
560 mg milligram(s)
Max total dose
560 mg milligram(s)
Max treatment duration
22 Month(s)
Authorisation status
Authorised
ATC code
L01EL01 — -
Marketing authorisation
EU/1/14/945/001
MA holder
JANSSEN-CILAG INTERNATIONAL NV
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Parsaclisib (INCB050465)

PRD10040591 · Product

Active substance
Parsaclisib Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
13990 mg milligram(s)
Max treatment duration
23 Month(s)
Authorisation status
Not Authorised
MA holder
INCYTE CORPORATION
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/19/2185

Parsaclisib (INCB050465)

PRD10040589 · Product

Active substance
Parsaclisib Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
13990 mg milligram(s)
Max treatment duration
23 Month(s)
Authorisation status
Not Authorised
MA holder
INCYTE CORPORATION
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/19/2185

Parsaclisib (INCB050465)

PRD4281347 · Product

Active substance
Parsaclisib Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
13990 mg milligram(s)
Max treatment duration
23 Month(s)
Authorisation status
Not Authorised
MA holder
INCYTE CORPORATION
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/19/2185

Parsaclisib (INCB050465)

PRD10040590 · Product

Active substance
Parsaclisib Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
13990 mg milligram(s)
Max treatment duration
23 Month(s)
Authorisation status
Not Authorised
MA holder
INCYTE CORPORATION
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/19/2185

MINJUVI 200 mg powder for concentrate for solution for infusion

PRD9171980 · Product

Active substance
Tafasitamab
Substance synonyms
MOR00208, HUMANIZED FC ENGINEERED MONOCLONAL ANTIBODY AGAINST CD19, MOR-208, XMAB-5574
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
12 mg/Kg milligram(s)/kilogram
Max total dose
552 mg/Kg milligram(s)/kilogram
Max treatment duration
23 Month(s)
Authorisation status
Authorised
ATC code
L01FX12 — -
Marketing authorisation
EU/1/21/1570/001
MA holder
INCYTE BIOSCIENCES DISTRIBUTION B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/14/1424
Modified vs. Marketing Authorisation
No

Auxiliary 1

Jakavi 5 mg tablets

PRD3949635 · Product

Active substance
Ruxolitinib
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
50 mg milligram(s)
Max total dose
34980 mg milligram(s)
Max treatment duration
23 Month(s)
Authorisation status
Authorised
ATC code
L01EJ01 — -
Marketing authorisation
EU/1/12/773/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

57 Total trials 21 Recruiting 32 Ended
Commercial
Sponsor organisation
Incyte Corp.
Address
1801 Augustine Cut Off
City
Wilmington
Postcode
19803-4404
Country
United States

Scientific contact point

Organisation
Incyte Corp.
Contact name
Clinical Trial Information

Public contact point

Organisation
Incyte Corp.
Contact name
Clinical Trial Information

Third parties 2

OrganisationCity, countryDuties
Suvoda LLC
ORG-100043523
 Conshohocken, United States Other
Syneos Health Netherlands B.V.
ORG-100013861
 Amsterdam, Netherlands On site monitoring, Code 10, Code 11, Code 12, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8

Locations

8 EU/EEA countries · 33 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 5 1
Czechia Ongoing, recruitment ended 4 2
Denmark Ended 32 3
France Ongoing, recruitment ended 32 4
Italy Ongoing, recruitment ended 32 8
Poland Ongoing, recruitment ended 5 3
Spain Ongoing, recruitment ended 33 11
Sweden Ended 1 1
Rest of world
United States, Turkey, Israel, Japan
 — 56 —

Investigational sites

Belgium

1 site · Ongoing, recruitment ended
Cliniques Universitaires Saint-Luc
Hematology Department, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Czechia

2 sites · Ongoing, recruitment ended
Fakultní Nemocnice Královské Vinohrady
Dermatovenerologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Vseobecna Fakultni Nemocnice V Praze
I. interní klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague 2

Denmark

3 sites · Ended
Aarhus University Hospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Department of Oncology and Haematology, Blegdamsvej 9, 2100, Copenhagen Oe
Zealand University Hospital
Department of Hematology, Sygehusvej 10, 4000, Roskilde

France

4 sites · Ongoing, recruitment ended
Institut Universitaire Du Cancer Toulouse-Oncopole
Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Hematology, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Antoine Lacassagne
Hematology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier Regional Et Universitaire De Brest
Hématologie Clinique, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2

Italy

8 sites · Ongoing, recruitment ended
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
MALATTIE ONCOLOGICHE ED EMATOLOGICHE, Via Pietro Albertoni 15, 40138, Bologna
Ospedale S. Eugenio
U.O.C. Ematologia, PIAZZALE DELL'UMANESIMO 10, 00144, ROMA
Azienda Ospedaliero Universitaria Pisana
Hematology, Via Roma 67, 56126, Pisa
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Unità Sanitaria Locale Della Romagna
Hematology, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Ospedaliera Universitaria Federico II Di Napoli
Ematologia e Trapianto di Midollo, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SDCU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Fondazione IRCCS Istituto Nazionale Dei Tumori
Ematologia – Trapianto di Midollo Osseo Allogenico, Via Giacomo Venezian 1, 20133, Milan

Poland

3 sites · Ongoing, recruitment ended
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu
Hematology, Ul. Mlynska 10, 33-300, Nowy Sacz
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie
Hematology, Ul. Stanislawa Staszica 11, 20-081, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Hematology, Internal diseases, Ul. Pabianicka 62, 93-513, Lodz

Spain

11 sites · Ongoing, recruitment ended
Institut Catala D'oncologia
Clinical Haematology Service, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Del Mar
Hematology and Hemotherapy, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital General Universitario Gregorio Maranon
Hematology and Hemotherapy, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Salamanca
Hematology Department, Paseo De San Vicente 58-182, 37007, Salamanca
University Hospital Virgen Del Rocio S.L.
Hematology and Hemotherapy, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Hematology and Hemotherapy, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Clinic De Barcelona
Hematology and Hemotherapy, Calle Villarroel 170, 08036, Barcelona
Catalan Institute Of Oncology
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Quironsalud Madrid
Hematology and Hemotherapy, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Hm Sanchinarro
Hematology and Hemotherapy, Calle Ona 10, 28050, Madrid
Hospital General Universitario Dr. Balmis
Hematology, Avinguda Del Pintor Baeza 12, 03010, Alicante

Sweden

1 site · Ended
Karolinska Institutet
Hematology, Nobels Vag 6, 171 65, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2020-10-28 2020-10-28 2024-01-11
Czechia 2024-04-16 2024-04-16 2024-04-17
Denmark 2021-03-24 2026-05-26 2021-03-24 2023-11-17
France 2021-02-05 2021-02-05 2024-07-16
Italy 2022-06-16 2022-06-16 2024-06-07
Poland 2024-04-24 2024-04-24 2024-08-21
Spain 2021-03-18 2021-03-18 2024-10-15

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2022-501687-18-00_Redacted 3-EU
Recruitment arrangements - Extract (for publication) K1_INCB50465 Subject Recruitment and Consent_Extract 2.0
Recruitment arrangements (for publication) K1_ Recruitment arrangement_IT NA
Recruitment arrangements (for publication) K1_INCB50465 Subject Recruitment and Consent 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangement_CZ NA
Recruitment arrangements (for publication) K1_Recruitment Arrangement_Subject Recruitment and Consent_DK 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_BE 3.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_ES 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_Obtaining informed consent_PL N/A
Recruitment arrangements (for publication) K2_Additional document_redacted 1.0
Recruitment arrangements (for publication) Recruitment arrangement_Blank document_BE_for publication 1
Recruitment arrangements (for publication) Recruitment arrangement_Blank document_ES_for publication 1
Recruitment arrangements (for publication) Recruitment arrangement_Blank document_FR_for publication 1
Recruitment arrangements (for publication) Recruitment arrangement_Blank document_IT_for publication 1
Subject information and informed consent form (for publication) L1_ SIS and ICF MAIN_IT 13.4.0
Subject information and informed consent form (for publication) L1_ SIS and ICF PP_IT_Redacted 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_FR_Final 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_FR_TC_redacted 7.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner_FR_Final_redacted 4.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner_FR_TC_redacted 3.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ ICF Pregnant Partner_PL 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Greenphire Consent_PL N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_Main 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_PL 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Privacy Notice_CZ 9.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_BE-EN 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_BE-FR 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_BE-NL 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_CZ 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_CZ_Ongoing 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_DK 13.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_BE-EN_Redacted 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_BE-FR_Redacted 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_BE-NL_Redacted 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_CZ 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_DK 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_DK_Extract 4.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_Privacy Notice_CZ 4.1.0
Subject information and informed consent form (for publication) L2_Other subject information material_GP letter_IT 2.4.0
Subject information and informed consent form (for publication) L2_Other subject information material_Reimbursement Procedures_IT_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Reimbursement Request Form_IT 1.0
Subject information and informed consent form (for publication) L2_Participant Card_CZ 3.0
Subject information and informed consent form (for publication) L2_SIS and ICF _ Pregnant Partner_Extract 4.1.0
Subject information and informed consent form (for publication) L2_SIS and ICF_Pregnant Partner 4.1.0
Subject information and informed consent form (for publication) SIS and ICF Main_FR_FP 7.1.0
Subject information and informed consent form (for publication) SIS and ICF Pregnant Partner_FR_FP 3.1.0
Summary of Product Characteristics (SmPC) (for publication) E1_SmPC_Imbruvica 1
Summary of Product Characteristics (SmPC) (for publication) E1_SmPC_Imbruvica 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_MOR00208 N/A
Synopsis of the protocol (for publication) D1_Protocol Synopsis SE_2022-501687-18-00 _Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-DE_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-FR_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE-NL_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2022-501687-18-00_Redacted 3-EU
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2022-501687-18-00_Redacted 3-EU

Application history

16 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-10-31 Spain Acceptable
2023-01-30
 2023-01-31
2 SUBSTANTIAL MODIFICATION SM-1 2023-02-28 Acceptable 2023-03-23
3 SUBSTANTIAL MODIFICATION SM-2 2023-02-28 2023-05-01
4 SUBSTANTIAL MODIFICATION SM-5 2023-03-02 Acceptable 2023-04-28
5 SUBSTANTIAL MODIFICATION SM-4 2023-03-15 Acceptable 2023-04-20
6 SUBSTANTIAL MODIFICATION SM-3 2023-03-20 Spain Acceptable 2023-05-10
7 SUBSTANTIAL MODIFICATION SM-6 2023-06-23 Spain Acceptable with conditions
2023-09-26
 2023-09-26
8 SUBSEQUENT ADDITION OF MSC APP-8 2023-10-11 Acceptable with conditions
2023-09-26
 2024-01-18
9 SUBSEQUENT ADDITION OF MSC APP-9 2023-10-13 Acceptable with conditions
2023-09-26
 2024-01-19
10 SUBSTANTIAL MODIFICATION SM-7 2023-10-13 Acceptable with conditions 2023-11-23
11 SUBSEQUENT ADDITION OF MSC APP-11 2023-10-17 2024-01-29
12 SUBSTANTIAL MODIFICATION SM-8 2024-02-07 Spain Acceptable
2024-04-01
 2024-04-03
13 SUBSTANTIAL MODIFICATION SM-9 2024-11-15 Spain Acceptable
2025-01-23
 2025-01-28
14 NON SUBSTANTIAL MODIFICATION NSM-1 2025-03-17 Acceptable
2025-01-23
 2025-03-17
15 SUBSTANTIAL MODIFICATION SM-10 2025-04-29 Spain Acceptable
2025-07-01
 2025-07-03
16 SUBSTANTIAL MODIFICATION SM-11 2025-12-17 Spain Acceptable
2026-03-09
 2026-03-10

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