A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Study Overview

• Status: Terminated
• Conditions: MPN (Myeloproliferative Neoplasms)
• Intervention / Treatment: Drug: Parsaclisib; Drug: Parsaclisib; Drug: Ruxolitinib; Drug: Parsaclisib; Drug: Parsaclisib

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Expanded Access

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Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223
      • Birmingham Hematology & Oncolgy Associates Llc
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Medical Center
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90095
      • UCLA School of Medicine
    • Pismo Beach, California, United States, 93449
      • PCR Oncology
    • San Marcos, California, United States, 92069
      • California Cancer Assoc. for Research and Excellence
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital
    • Bethesda, Maryland, United States, 20817
      • Cancer Center For Blood Disorders
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University School of Medicine
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Cancer Care Alliance
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45230
      • Oncology Hematology Care, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Rush University Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott and White Research Institute
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78217
      • Cancer Care Centers of South Texas
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical Consultants Llc
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • VA Salt Lake City Health Care System
  • Washington
    • Olympia, Washington, United States, 98506
      • Vista Oncology Inc PS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
• Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
• Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

• Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy 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
• Unwillingness to be transfused with blood components

• Recent history of inadequate bone marrow reserve as demonstrated by the following:

  • Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
  • Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening
  • Subjects with peripheral blood blast count of > 10% at the screening or baseline hematology assessments
  • Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels

• Inadequate liver function at screening as demonstrated by the following:

  • Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
• Inadequate renal function at screening as demonstrated by creatinine clearance < 50 mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Ruxolitinib + Parsaclisib; Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.	Drug: Parsaclisib; Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Parsaclisib; Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Ruxolitinib; The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.; Other Names: Jakafi®; Drug: Parsaclisib; 20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.; Other Names: INCB050465; Drug: Parsaclisib; 2 dose strategies will be compared: 5 mg parsaclisib beginning on Day 1 until end of treatment.; 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.; Other Names: INCB050465
Experimental: Part 2: Ruxolitinib + Parsaclisib; Part 2 will compare 2 doses of parsaclisib .	Drug: Parsaclisib; Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Parsaclisib; Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Ruxolitinib; The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.; Other Names: Jakafi®; Drug: Parsaclisib; 20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.; Other Names: INCB050465; Drug: Parsaclisib; 2 dose strategies will be compared: 5 mg parsaclisib beginning on Day 1 until end of treatment.; 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.; Other Names: INCB050465
Experimental: Part 3: Ruxolitinib + Parsaclisib; Part 3 will compare 2 different long term dosing strategies.	Drug: Parsaclisib; Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Parsaclisib; Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Ruxolitinib; The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.; Other Names: Jakafi®; Drug: Parsaclisib; 20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.; Other Names: INCB050465; Drug: Parsaclisib; 2 dose strategies will be compared: 5 mg parsaclisib beginning on Day 1 until end of treatment.; 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.; Other Names: INCB050465
Experimental: Part 4: Ruxolitinib + Parsaclisib; Part 4 will compare 2 different daily dosing strategies.	Drug: Parsaclisib; Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Parsaclisib; Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.; Other Names: INCB050465; Drug: Ruxolitinib; The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.; Other Names: Jakafi®; Drug: Parsaclisib; 20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.; Other Names: INCB050465; Drug: Parsaclisib; 2 dose strategies will be compared: 5 mg parsaclisib beginning on Day 1 until end of treatment.; 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.; Other Names: INCB050465

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)	DLTs were defined as the occurrence of any protocol-defined toxicities occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression, other medications) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria.	up to Day 28
Change From Baseline in Spleen Volume Through Week 12 of the Initial Study Period as Measured by Magnetic Resonance Imaging (MRI) (or Computed Tomography [CT] Scan in Applicable Participants)	Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 12
Percent Change From Baseline in Spleen Volume Through Week 12 as Measured by MRI (or CT Scan in Applicable Participants)	Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Spleen Volume Through Week 24 of the Initial Study Period as Measured by MRI (or CT Scan in Applicable Participants)	Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 24
Percent Change From Baseline in Spleen Volume Through Week 24 as Measured by MRI (or CT Scan in Applicable Participants )	Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 24
Change From Baseline in the Total Symptom Score (TSS) Through Week 12 as Measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 3.0 (v3.0) Symptom Diary	The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.	Baseline; Week 12
Percent Change From Baseline in the TSS Through Week 12 as Measured by MFSAF v3.0 Symptom Diary	The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 12 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 12 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 12
Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary	The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.	Baseline; Week 24
Percent Change From Baseline in the TSS Through Week 24 as Measured by MFSAF v3.0 Symptom Diary	The MFSAF v3.0 is comprised of 19 individual symptom scores, each collected daily using an 11-point scale. The daily TSS is composed of 6 of these individual symptom scores (nights sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone/muscle pain) collected on the same day. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 6 symptom scores; scores ranged from 0 to 60, with higher scores corresponding to more severe symptoms. The Baseline TSS was defined as the average of daily total scores from the last 7 days before the first dose of INCB050465. The Week 24 TSS was the average of the daily total scores from the last 7 consecutive days before the Week 24 visit. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 24
Change From Baseline in the TSS Through Week 12 as Measured by Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)	The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.	Baseline; Week 12
Percent Change From Baseline in the TSS Through Week 12 as Measured by MPN-SAF	The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 12
Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF	The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.	Baseline; Week 24
Percent Change From Baseline in the TSS Through Week 24 as Measured by MPN-SAF	The MPN-SAF weekly total score is defined as the sum of 10 individual symptom scores (fatigue, nights sweats, itchiness, bone pain, fever, unintentional weight loss last 6 months, early satiety, abdominal discomfort, inactivity, problems with concentration) collected at the same visit using an 11-point scale. Participants scored each symptom using a scale from 0 (absent) to 10 (worst imaginable). The TSS was calculated as a sum of all 10 symptom scores; scores ranged from 0 to 100, with higher scores corresponding to more severe symptoms. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) x 100.	Baseline; Week 24
Number of Participants With the Indicated Patient Global Impression of Change (PGIC) Score at Week 12, Week 24, and the End of Treatment (EOT)	The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."	Baseline; up to 1494 days (EOT)
Mean PGIC Score at Week 12, Week 24, and the EOT	The PGIC questionnaire consists of a single question with 7 possible answers: "Since the start of treatment you've received in this study, your myelofibrosis symptoms are: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse."	up to 1494 days (EOT)
Best Overall Response (Percentage of Participants With Complete Response [CR] or Partial Response [PR]) for Investigator-Reported International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Response Assessment	A participant was considered as a responder if the participant had a best overall response of CR or PR. CR: (a) bone marrow (BM): age-adjusted normocellularity (AAN); < 5% blasts; ≤ grade 1 myelofibrosis (MF); (b) peripheral blood (PD): hemoglobin (Hg) ≥ 100 grams per Liter (g/L) and < upper normal limit (UNL); neutrophils ≥ 1 × 10^9/L and < UNL; (c) platelets ≥ 100 × 10^9/L and < UNL; < 2% immature myeloid cells (IMCs); (d) clinical: resolution of disease symptoms; spleen/liver not palpable; no extramedullary hematopoiesis (EMH). PR: (a) PB: Hg ≥ 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 100 × 10^9/L and < UNL; < 2% IMCs; (b) clinical: resolution of disease symptoms; spleen/liver not palpable; no EMH; (c) BM: AAN; < 5% blasts; ≤ Grade 1 MF; and PB: Hg ≥ 85 g/L but < 100 g/L and < UNL; neutrophils ≥ 1 × 10^9/L and < UNL; platelets ≥ 50 × 10^9/L but < 100 × 10^9/L and < UNL; < 2% IMCs.	Week 12 and every 12 weeks thereafter (up to 1494 days [EOT])
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug.	up to approximately 4 years
Number of Participants With Any TEAE During the Transition Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or requird changes in the study drug(s). TEAEs were defined as AEs that began or worsened from Baseline after the first administration of study drug. Participants who had been assigned to dosing arms with weekly dosing beyond Week 8 had the opportunity to transition to all daily dosing at 5 mg if agreed upon by the participant and the Investigator.	up to approximately 4 years
Cmax of Parsaclisib	Cmax was defined as the maximum observed plasma concentration.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Tmax of Parsaclisib	tmax was defined as the time to the maximum concentration.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmin of Parsaclisib	Cmin was defined as the minimum observed plasma concentration.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-4h of Parsaclisib	AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-t of Parsaclisib	AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Clast of Parsaclisib	Clast was defined as the last quantifiable concentration.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Tlast of Parsaclisib	tlast was defined as the time of the last quantifiable concentration.	Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmax of Ruxolitinib	Cmax was defined as the maximum observed plasma concentration.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Tmax of Ruxolitinib	tmax was defined as the time to the maximum concentration.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Cmin of Ruxolitinib	Cmin was defined as the minimum observed plasma concentration.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-4h of Ruxolitinib	AUC0-4h was defined as the area under the plasma concentration-time curve from time = 0 to 4 hours post-dose.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
AUC0-t of Ruxolitinib	AUC0-t was defined as the area under the plasma concentration-time curve from time =0 to the last measurable concentration at time = t.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Clast of Ruxolitinib	Clast was defined as the last quantifiable concentration.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose
Tlast of Ruxolitinib	tlast was defined as the time of the last quantifiable concentration.	Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Albert Assad, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimated): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Janus kinase (JAK) inhibitor; Primary myelofibrosis (PMF); post-polycythemia vera myelofibrosis (PPV-MF); post-essential thrombocythemia myelofibrosis (PET-MF); myeloproliferative neoplasms (MPNs); phosphoinositide 3-kinase (PI3K) inhibitor
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Primary Myelofibrosis; Myeloproliferative Disorders
• Other Study ID Numbers: INCB 50465-201; Parsaclisib (Other Identifier: Incyte Corporation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No