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

Primary Purpose

Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
parsaclisib
ruxolitinib
placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring INCB050465, ruxolitinib, parsaclisib, LIMBER, LIMBER-304, MF, MPN, Myeloproliferative Neoplasm, Myelofibrosis, Myoproliferative Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center
  • CCARE
  • California Research Institute (Cri)
  • Emad Ibrahim Md Inc
  • Scripps Clinic
  • Coastal Integrated Cancer Care - Cicc
  • Stamford Hospital - Medical Oncology Hematology
  • Georgetown University
  • Emory University
  • Augusta University - Medical College of Georgia
  • Indiana University Melvin and Bren Simon Cancer Center
  • University of Kansas Hospital Authority
  • Tulane University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Midamerica Cancer Care
  • New Jersey Hematology Oncology Associates Llc
  • Morristown Medical Center - Atlantic Health System
  • Montefiore Medical Center
  • Westchester Medical Center Advanced Oncology
  • Mount Sinai School of Medicine
  • Memorial Sloan Kettering Cancer Center
  • Advent Health Hendersonville Park Ridge Hospital Hendersonville
  • Duke Cancer Center
  • Cleveland Clinic
  • Oregon Health & Science University
  • Oregon Health & Science University
  • Hillman Cancer Center
  • Baptist Cancer Center
  • Texas Oncology - Medical City Dallas
  • Texas Oncology - Baylor Sammons Cancer Center
  • University of Texas Southwestern Medical Center
  • Renovatio Clinical
  • Kelsey Seybold Clinic
  • Providence Regional Medical Center Everett
  • Hanusch-Krankenhaus Wiener Gebietskrankenkasse
  • A.Z. St.-Jan A.V.
  • Jessa Ziekenhuis
  • AZ Delta
  • Chu Ucl Namur University Hospital Mont-Godinne
  • Peking University People'S Hospital (Pkuph) - Institute of Hematology
  • Xuanwu Hospital Capital Medical University
  • Peking University Third Hospital
  • Peking University Third Hospital
  • The First Hospital of Jilin University
  • The First Peoples Hospital of Changzhou
  • Fujian Medical University Union Hospital
  • Nanfang Hospital
  • The First Affiliated Hospital of Zhejiang University
  • Harbin Institute of Hematology and Oncology
  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
  • The Affiliated Hospital of Inner Mongolia Medical University
  • Jinan Central Hospital
  • The Second Affiliated Hospital of Kunming Medical University
  • The First Hospital of Lanzhou University
  • Lanzhou University Second Hospital
  • Jiangxi Provincial of People Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jiangsu Province Hospital
  • The Affiliated Hospital of Qingdao University
  • The First Hospital of China Medical University
  • Shenzhen University Hospital
  • Tianjin Medical University General Hospital
  • Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek
  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Tongji Hospital Huazhong University of Science and Technology
  • The Second Affiliated Hospital of Xi an Jiaotong University
  • Yantai Yuhuangding Hospital
  • Henan Provincial Peoples Hospital
  • Henan Cancer Hostipal
  • Helsinki University Central Hospital
  • Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
  • Chu de Limoges
  • CHU Limoges - Hopital Duputren
  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Chu Nimes
  • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
  • Hospital Saint Antoine
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Institut Universitaire Du Cancer de Toulouse Oncopole
  • Chu Vandoeuvre-Les-Nancy Hopital Brabois
  • Universitatsklinikum Bonn Aoer
  • Universitaetsmedizin Greifswald
  • Universitatsklinikum Halle (Saale)
  • Universitaetsmedizin Rostock
  • Semmelweis Egyetem
  • Markhot Ferenc Korhaz
  • Petz Aladar County Teaching Hospital
  • Samson Assuta Ashdod University Hospital
  • Rambam Health Care Campus
  • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Assuta Ramat Hahayal
  • Azienda Ospedaliera San Giuseppe Moscati
  • Aou Policlinico Consorziale Di Bari
  • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
  • University of Florence
  • Irccs Azienda Ospedaliera Universitaria San Martino
  • Fondazione Irccs Ca Granda Ospedale Maggiore
  • Universita Di Napoli Federico Ii
  • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
  • Ospedale S.Maria Della Misericordia
  • Ospedale S.Maria Della Misericordia
  • Presidio Ospedaliero Pescara
  • Azienda Ospedaliero Universitaria Pisana
  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
  • Univ. Di Roma Facolta Di Armacia E Medicina
  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
  • Ospedale Sant. Eugenio
  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
  • Azienda Ospedaliera San Giuseppe Moscati
  • Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
  • A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi
  • Kyushu University Hospital
  • Japanese Red Cross Society Himeji Hospital
  • Kansai Medical University Hospital
  • Tokai University Hospital
  • Juntendo University Hospital
  • Kagoshima University Hospital
  • Hospital of the University of Occupation and Environmental Health
  • Kobe City Medical Center General Hospital
  • Kumamoto Shinto General Hospital
  • University of Miyazaki Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • Ogaki Municipal Hospital
  • Osaka Metropolitan University Hospital
  • Dokkyo Medical University Saitama Medical Center
  • Hokuyukai Sapporo Hokuyu Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • University of Yamanashi Hospital
  • Pusan National University Yangsan Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary?S Hospital
  • Haukeland University Hospital
  • Akershus University Hospital
  • Pratia Hematologia Katowice
  • Pratia Hematologia Katowice
  • Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Institute of Hematology and Transfusion Medicine
  • Spitalul Clinic Coltea - Clinica Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Hospital General Unviersitario de Alicante
  • Ico Hospital Germans Trias I Pujol
  • Hospital Del Mar
  • Hospital General Universitario Vall D Hebron
  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
  • Hospital Universitario Insular de Gran Canaria
  • Hospital Universitario 12 de Octubre
  • Fundacion Jimenez Diaz University Hospital
  • Hospital General Universitario Morales Meseguer
  • Hospital Universitario Virgen de La Arrixaca
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitario Virgen Del Rocio
  • Hospital Universitari I Politecnic La Fe
  • Hospital Universitario Doctor Peset
  • Hospital Universitario Miguel Servet
  • Kaohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Cheng Kung University (Ncku) Hospital
  • Baskent University Adana Hospital
  • Gazi University Hospital Gazi University Faculty of Medicine
  • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
  • Baskent University Istanbul Hospital
  • Ege University Hospital
  • Ondokuz Mayis University Medicine Faculty
  • Grampian Health Board
  • United Lincolnshire Hospitals
  • Gloucestershire Royal Hospital
  • University College London Hospitals Nhs Foundation Trust
  • James Cook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A : ruxolitinib +parsaclisib

Group B : ruxolitinib + placebo

Arm Description

Participants will receive parsaclisib starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.

Participants will receive placebo starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.

Outcomes

Primary Outcome Measures

Proportion of participants achieving targeted reduction in spleen volume
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).

Secondary Outcome Measures

Proportion of participants who have a targeted reduction in Total Symptom Score (TSS)
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Change in TSS
Change in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time to the first ≥ 50% reduction in TSS
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Overall Survival (OS)
OS is defined as randomization date to death due to any cause
Number of Treatment Emergent Adverse Events (TEAE)
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 35 days after last dose of study drug.
Time of onset of targeted reduction in spleen volume
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Duration of maintenance of targeted reduction in spleen volume
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).

Full Information

First Posted
September 11, 2020
Last Updated
October 17, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04551053
Brief Title
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
Keywords
INCB050465, ruxolitinib, parsaclisib, LIMBER, LIMBER-304, MF, MPN, Myeloproliferative Neoplasm, Myelofibrosis, Myoproliferative Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple blind
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A : ruxolitinib +parsaclisib
Arm Type
Experimental
Arm Description
Participants will receive parsaclisib starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.
Arm Title
Group B : ruxolitinib + placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.
Intervention Type
Drug
Intervention Name(s)
parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
parsaclisib will be administered QD orally
Intervention Type
Drug
Intervention Name(s)
ruxolitinib
Other Intervention Name(s)
Jakafi, Jakavi
Intervention Description
ruxolitinib will be administered BID orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo will be administered QD orally
Primary Outcome Measure Information:
Title
Proportion of participants achieving targeted reduction in spleen volume
Description
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants who have a targeted reduction in Total Symptom Score (TSS)
Description
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time Frame
Baseline to Week 24
Title
Change in TSS
Description
Change in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time Frame
Baseline to Week 24
Title
Time to the first ≥ 50% reduction in TSS
Description
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time Frame
Baseline to Week 24
Title
Overall Survival (OS)
Description
OS is defined as randomization date to death due to any cause
Time Frame
Up to approximately 36 months
Title
Number of Treatment Emergent Adverse Events (TEAE)
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 35 days after last dose of study drug.
Time Frame
Up to approximately 36 months
Title
Time of onset of targeted reduction in spleen volume
Description
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Time Frame
Baseline to Week 108
Title
Duration of maintenance of targeted reduction in spleen volume
Description
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Time Frame
Baseline to Week 108

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Assad, M.D.
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
CCARE
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
California Research Institute (Cri)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-6005
Country
United States
Facility Name
Emad Ibrahim Md Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Coastal Integrated Cancer Care - Cicc
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Stamford Hospital - Medical Oncology Hematology
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University - Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Hospital Authority
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Midamerica Cancer Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
New Jersey Hematology Oncology Associates Llc
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Morristown Medical Center - Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Westchester Medical Center Advanced Oncology
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Advent Health Hendersonville Park Ridge Hospital Hendersonville
City
Clyde
State/Province
North Carolina
ZIP/Postal Code
28721
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2092
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8565
Country
United States
Facility Name
Renovatio Clinical
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Kelsey Seybold Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
City
Wien
ZIP/Postal Code
01140
Country
Austria
Facility Name
A.Z. St.-Jan A.V.
City
Brugge
ZIP/Postal Code
08000
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Chu Ucl Namur University Hospital Mont-Godinne
City
Yvoir
ZIP/Postal Code
05530
Country
Belgium
Facility Name
Peking University People'S Hospital (Pkuph) - Institute of Hematology
City
Beijing SHI
ZIP/Postal Code
100044
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100091
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
The First Peoples Hospital of Changzhou
City
Changzhou
ZIP/Postal Code
213003
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Harbin Institute of Hematology and Oncology
City
Harbin
ZIP/Postal Code
150010
Country
China
Facility Name
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
ZIP/Postal Code
10050
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
ZIP/Postal Code
650101
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Jiangxi Provincial of People Hospital
City
Nanchang
ZIP/Postal Code
330000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Shenzhen University Hospital
City
Shenzhen
ZIP/Postal Code
518055
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek
City
Tianjin
ZIP/Postal Code
510080
Country
China
Facility Name
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
The Second Affiliated Hospital of Xi an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264000
Country
China
Facility Name
Henan Provincial Peoples Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Henan Cancer Hostipal
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FI-00029
Country
Finland
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Chu de Limoges
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
CHU Limoges - Hopital Duputren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Chu Nimes
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hospital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Universitaire Du Cancer de Toulouse Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Chu Vandoeuvre-Les-Nancy Hopital Brabois
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle (saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
01088
Country
Hungary
Facility Name
Markhot Ferenc Korhaz
City
Eger
ZIP/Postal Code
03300
Country
Hungary
Facility Name
Petz Aladar County Teaching Hospital
City
Gyor
ZIP/Postal Code
09024
Country
Hungary
Facility Name
Samson Assuta Ashdod University Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31999
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center Ein Karem Hadassah
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assuta Ramat Hahayal
City
Tel Aviv
ZIP/Postal Code
69710
Country
Israel
Facility Name
Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Aou Policlinico Consorziale Di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
City
Catania
ZIP/Postal Code
11111
Country
Italy
Facility Name
University of Florence
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Irccs Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Irccs Ca Granda Ospedale Maggiore
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Universita Di Napoli Federico Ii
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale S.Maria Della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Ospedale S.Maria Della Misericordia
City
Perugia
ZIP/Postal Code
6156
Country
Italy
Facility Name
Presidio Ospedaliero Pescara
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
City
Reggio Calabria
ZIP/Postal Code
89133
Country
Italy
Facility Name
Univ. Di Roma Facolta Di Armacia E Medicina
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Sant. Eugenio
City
Roma
ZIP/Postal Code
144
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera San Giuseppe Moscati
City
Taranto
ZIP/Postal Code
74123
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Himeji-shi
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
ZIP/Postal Code
2591193
Country
Japan
Facility Name
Juntendo University Hospital
City
Izunokuni
ZIP/Postal Code
410-2211
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Hospital of the University of Occupation and Environmental Health
City
Kitakyushu-shi
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto-shi
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya-shi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Hokuyukai Sapporo Hokuyu Hospital
City
Sapporo
ZIP/Postal Code
003-0006
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Pusan National University Yangsan Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary?S Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
05021
Country
Norway
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
01478
Country
Norway
Facility Name
Pratia Hematologia Katowice
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Pratia Hematologia Katowice
City
Katowice
ZIP/Postal Code
41-081
Country
Poland
Facility Name
Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Institute of Hematology and Transfusion Medicine
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Spitalul Clinic Coltea - Clinica Hematologie
City
Bucharest,
ZIP/Postal Code
30171
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures
City
Targu
ZIP/Postal Code
540139
Country
Romania
Facility Name
Hospital General Unviersitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Ico Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
24041
Country
Spain
Facility Name
Fundacion Jimenez Diaz University Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari I Politecnic La Fe
City
Valencia
ZIP/Postal Code
46000
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
00404
Country
Taiwan
Facility Name
National Cheng Kung University (Ncku) Hospital
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Baskent University Adana Hospital
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Gazi University Hospital Gazi University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Baskent University Istanbul Hospital
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Ege University Hospital
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Ondokuz Mayis University Medicine Faculty
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Grampian Health Board
City
Aberdeen
ZIP/Postal Code
AB15 6RE
Country
United Kingdom
Facility Name
United Lincolnshire Hospitals
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
University College London Hospitals Nhs Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Links:
URL
https://www.incyteclinicaltrials.com/limber/
Description
Related Info

Learn more about this trial

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

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