Myeloproliferative Neoplasms Clinical Trial

To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Summary

The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

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Full Description

Prospective participants must be on stable doses of ruxolitinib ranging from 5 mg BID to 25 mg BID and will have been on that dose for at least the last 8 weeks prior to Day 1. At least 3 months duration of prior ruxolitinib is required. Participants must meet Protocol-defined criteria for suboptimal response to ruxolitinib monotherapy. After participants have been determined to be eligible for the study and completed the baseline symptom diary assessment for 7 days, they will be randomized to 1 of 2 treatment groups, with stratification for platelet count (≥ 100 × 10^9/L vs 50 to < 100 × 10^9/L inclusive) and DIPSS risk category (high vs intermediate-2 vs intermediate-1).

Once a participant has completed the week 24 assessments, the participant's treatment assignment will then be unblinded and if found to be placebo, the participant will have the opportunity to crossover to begin receiving parsaclisib, together with continued ruxolitinib, as long as hematology parameters are adequate.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of PMF, PPV-MF, or PET-MF.
DIPSS risk category of intermediate-1, intermediate-2, or high.
Treated with ruxolitinib for ≥ 3 months with a stable dose for at least the last 8 weeks prior to Day 1
Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit.
Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form.
Participants with an ECOG performance status score of 0, 1, or 2.
Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.
Life expectancy of at least 24 weeks.
Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib).
Use of experimental drug therapy for MF or any other standard drug used for MF (whether for treatment of MF or another indication) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
Recent history of inadequate bone marrow reserve.
Inadequate liver and renal function at screening.
Active bacterial, fungal, parasitic, or viral infection that requires therapy.
Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.
Known HIV infection.
Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol.
Active invasive malignancy over the previous 2 years.
Splenic irradiation within 6 months before receiving the first dose of study drug.
Concurrent use of any prohibited medications.
Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements.
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study.
Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Currently breastfeeding or pregnant.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
History of Grade 3 or 4 irAEs from prior immunotherapy.
Receipt of any live vaccine within 30 days of the first dose of study drug
Unwillingness to receive RBC transfusions to treat low hemoglobin levels.
Known hypersensitivity or severe reaction to parsaclisib or ruxolitinib or excipients of parsaclisib/matching placebo or ruxolitinib formulations.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

212

Study ID:

NCT04551053

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 172 Locations for this study

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Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center
Berkeley California, 94704, United States
CCARE
Fresno California, 93720, United States
California Research Institute (Cri)
Los Angeles California, 90027, United States
Emad Ibrahim Md Inc
Redlands California, 92373, United States
Scripps Clinic
San Diego California, 92103, United States
Coastal Integrated Cancer Care - Cicc
San Luis Obispo California, 93401, United States
Stamford Hospital - Medical Oncology Hematology
Stamford Connecticut, 06904, United States
Georgetown University
Washington District of Columbia, 20057, United States
Emory University
Atlanta Georgia, 30322, United States
Augusta University - Medical College of Georgia
Augusta Georgia, 30912, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Kansas Hospital Authority
Westwood Kansas, 66205, United States
Tulane University
New Orleans Louisiana, 70112, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess
Boston Massachusetts, 02215, United States
Midamerica Cancer Care
Kansas City Missouri, 64114, United States
New Jersey Hematology Oncology Associates Llc
Brick New Jersey, 08724, United States
Morristown Medical Center - Atlantic Health System
Morristown New Jersey, 07960, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Westchester Medical Center Advanced Oncology
Hawthorne New York, 10532, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Advent Health Hendersonville Park Ridge Hospital Hendersonville
Clyde North Carolina, 28721, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Columbus Ohio, 43210, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Renovatio Clinical
Houston Texas, 77005, United States
Kelsey Seybold Clinic
Houston Texas, 77025, United States
Providence Regional Medical Center
Everett Washington, 98201, United States
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
Wien , 01140, Austria
A.Z. St.-Jan A.V.
Brugge , 08000, Belgium
Jessa Ziekenhuis
Hasselt , 3500, Belgium
AZ Delta
Roeselare , 8800, Belgium
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir , 05530, Belgium
Peking University People'S Hospital (Pkuph) - Institute of Hematology
Beijing , 10004, China
Xuanwu Hospital Capital Medical University
Beijing , 10005, China
Peking University Third Hospital
Beijing , 10009, China
Peking University Third Hospital
Beijing , 10019, China
The First Hospital of Jilin University
Changchun , 13002, China
The First Peoples Hospital of Changzhou
Changzhou , 21300, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
Nanfang Hospital
Guangzhou , 51051, China
The First Affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Harbin Institute of Hematology and Oncology
Harbin , 15001, China
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei , 23002, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot , 10050, China
Jinan Central Hospital
Jinan , 25001, China
The Second Affiliated Hospital of Kunming Medical University
Kunming , 65010, China
The First Hospital of Lanzhou University
Lanzhou , 73000, China
Lanzhou University Second Hospital
Lanzhou , 73003, China
Jiangxi Provincial of People Hospital
Nanchang , 33000, China
The First Affiliated Hospital of Nanchang University
Nanchang , 33000, China
Jiangsu Province Hospital
Nanjing , 21002, China
The Affiliated Hospital of Qingdao University
Qingdao , 26600, China
The First Hospital of China Medical University
Shenyang , 11000, China
Shenzhen University Hospital
Shenzhen , 51805, China
Tianjin Medical University General Hospital
Tianjin , 30005, China
Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek
Tianjin , 51008, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43002, China
Tongji Hospital Huazhong University of Science and Technology
Wuhan , 43003, China
The Second Affiliated Hospital of Xi an Jiaotong University
Xi'an , 71000, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Provincial Peoples Hospital
Zhengzhou , 45000, China
Henan Cancer Hostipal
Zhengzhou , 45000, China
Helsinki University Central Hospital
Helsinki , FI-00, Finland
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
La Tronche , 38700, France
Chu de Limoges
Limoges Cedex , 87042, France
CHU Limoges - Hopital Duputren
Limoges Cedex , 87042, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes , 44093, France
Chu Nimes
Nimes , 30900, France
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
Paris , 75010, France
Hospital Saint Antoine
Paris , 75012, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Benite , 69495, France
Institut Universitaire Du Cancer de Toulouse Oncopole
Toulouse , 31059, France
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandoeuvre-les-nancy , 54500, France
Universitatsklinikum Bonn Aoer
Bonn , 53127, Germany
Universitaetsmedizin Greifswald
Greifswald , 17475, Germany
Universitatsklinikum Halle (Saale)
Halle (saale) , 06120, Germany
Universitaetsmedizin Rostock
Rostock , 18057, Germany
Semmelweis Egyetem
Budapest , 01088, Hungary
Markhot Ferenc Korhaz
Eger , 03300, Hungary
Petz Aladar County Teaching Hospital
Gyor , 09024, Hungary
Samson Assuta Ashdod University Hospital
Ashdod , 77476, Israel
Rambam Health Care Campus
Haifa , 31999, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem , 91120, Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Assuta Ramat Hahayal
Tel Aviv , 69710, Israel
Azienda Ospedaliera San Giuseppe Moscati
Avellino , 83100, Italy
Aou Policlinico Consorziale Di Bari
Bari , 70124, Italy
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
Bologna , 40138, Italy
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania , 11111, Italy
University of Florence
Florence , 50134, Italy
Irccs Azienda Ospedaliera Universitaria San Martino
Genova , 16132, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milano , 20122, Italy
Universita Di Napoli Federico Ii
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
Novara , 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo , 90146, Italy
Ospedale S.Maria Della Misericordia
Perugia , 06156, Italy
Ospedale S.Maria Della Misericordia
Perugia , 6156, Italy
Presidio Ospedaliero Pescara
Pescara , 65124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa , 56126, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria , 89133, Italy
Univ. Di Roma Facolta Di Armacia E Medicina
Roma , 00161, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma , 00168, Italy
Ospedale Sant. Eugenio
Roma , 144, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome , 00168, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena , 53100, Italy
Azienda Ospedaliera San Giuseppe Moscati
Taranto , 74123, Italy
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
Udine , 33100, Italy
A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi
Varese , 21100, Italy
Kyushu University Hospital
Fukuoka , 812-8, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi , 670-8, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Tokai University Hospital
Isehara , 25911, Japan
Juntendo University Hospital
Izunokuni , 410-2, Japan
Kagoshima University Hospital
Kagoshima , 890-8, Japan
Hospital of the University of Occupation and Environmental Health
Kitakyushu-shi , 807-8, Japan
Kobe City Medical Center General Hospital
Kobe-shi , 650-0, Japan
Kumamoto Shinto General Hospital
Kumamoto-shi , 862-8, Japan
University of Miyazaki Hospital
Miyazaki , 889-1, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya-shi , 453-8, Japan
Ogaki Municipal Hospital
Ogaki , 50385, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Dokkyo Medical University Saitama Medical Center
Saitama , 343-8, Japan
Hokuyukai Sapporo Hokuyu Hospital
Sapporo , 003-0, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
University of Yamanashi Hospital
Yamanashi , 409-3, Japan
Pusan National University Yangsan Hospital
Busan , 49241, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary?S Hospital
Seoul , 06591, Korea, Republic of
Haukeland University Hospital
Bergen , 05021, Norway
Akershus University Hospital
Lorenskog , 01478, Norway
Pratia Hematologia Katowice
Katowice , 40-04, Poland
Pratia Hematologia Katowice
Katowice , 41-08, Poland
Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie
Krakow , 31-50, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin , 20-08, Poland
Institute of Hematology and Transfusion Medicine
Warszawa , 02-77, Poland
Spitalul Clinic Coltea - Clinica Hematologie
Bucharest , 30171, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureș , 54013, Romania
Hospital General Unviersitario de Alicante
Alicante , 03010, Spain
Ico Hospital Germans Trias I Pujol
Badalona , 08916, Spain
Hospital Del Mar
Barcelona , 08003, Spain
Hospital General Universitario Vall D Hebron
Barcelona , 08035, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
Barcelona , 08908, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria , 35010, Spain
Hospital Universitario 12 de Octubre
Madrid , 24041, Spain
Fundacion Jimenez Diaz University Hospital
Madrid , 28040, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Hospital Universitario Virgen de La Arrixaca
Murcia , 30120, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Hospital Universitari I Politecnic La Fe
Valencia , 46000, Spain
Hospital Universitario Doctor Peset
Valencia , 46017, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City , 83301, Taiwan
China Medical University Hospital
Taichung , 00404, Taiwan
National Cheng Kung University (Ncku) Hospital
Tainan , 00704, Taiwan
Baskent University Adana Hospital
Adana , 01250, Turkey
Gazi University Hospital Gazi University Faculty of Medicine
Ankara , 06500, Turkey
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
Istanbul , 34214, Turkey
Baskent University Istanbul Hospital
Istanbul , 34662, Turkey
Ege University Hospital
Izmir , 35040, Turkey
Ondokuz Mayis University Medicine Faculty
Samsun , 55200, Turkey
Grampian Health Board
Aberdeen , AB15 , United Kingdom
United Lincolnshire Hospitals
Boston , PE21 , United Kingdom
Gloucestershire Royal Hospital
Gloucester , GL1 3, United Kingdom
University College London Hospitals Nhs Foundation Trust
London , NW1 2, United Kingdom
James Cook University Hospital
Middlesbrough , TS4 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

212

Study ID:

NCT04551053

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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