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MPN (Myeloproliferative Neoplasms)Phase 2NCT02718300

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

A Phase 2 study testing Parsaclisib and Ruxolitinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 39 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
MPN (Myeloproliferative Neoplasms)
What is being tested?
Parsaclisib and Ruxolitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
39 sitesUnited States
Study dates
8 Feb 2017to 29 Apr 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • McFarland Clinic

    Ames, Iowa, 50010

  • Emory University

    Atlanta, Georgia, 30322

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Alta Bates Medical Center

    Berkeley, California, 94704

  • Cancer Center For Blood Disorders

    Bethesda, Maryland, 20817

  • Birmingham Hematology & Oncolgy Associates Llc

    Birmingham, Alabama, 35223

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • California Cancer Associates For Research and Excellence

    Fresno, California, 93720

  • Shands Hospital

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Md Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • University of Southern California

    Los Angeles, California, 90033

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Rush University Medical Center

    Nashville, Tennessee, 37203

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Vista Oncology Inc Ps

    Olympia, Washington, 98506

  • Pcr Oncology

    Pismo Beach, California, 93449

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Va Salt Lake City Health Care System

    Salt Lake City, Utah, 84112

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • California Cancer Assoc. for Research and Excellence

    San Marcos, California, 92069

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63130

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Renovatio Clinical Consultants Llc

    The Woodlands, Texas, 77380

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: 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.

Being tested
Parsaclisib, Ruxolitinib
Keywords
Primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (PET-MF), myeloproliferative neoplasms (MPNs), phosphoinositide 3-kinase (PI3K) inhibitor, Janus kinase (JAK) inhibitor
Medical subject headings
Myeloproliferative Disorders, Primary Myelofibrosis, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParsaclisibDrug

    Also called INCB050465

    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.

  • ParsaclisibDrug

    Also called INCB050465

    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.

  • RuxolitinibDrug

    Also called Jakafi®

    The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.

  • ParsaclisibDrug

    Also called INCB050465

    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.

  • ParsaclisibDrug

    Also called INCB050465

    2 dose strategies will be compared:

    1. 5 mg parsaclisib beginning on Day 1 until end of treatment.
    2. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.
Study groups in NCT02718300
Study groupRoleWhat they receive
Part 1: Ruxolitinib + ParsaclisibExperimentalInitial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
Receives: Drug: Parsaclisib; Drug: Ruxolitinib
Part 2: Ruxolitinib + ParsaclisibExperimentalPart 2 will compare 2 doses of parsaclisib .
Receives: Drug: Parsaclisib; Drug: Ruxolitinib
Part 3: Ruxolitinib + ParsaclisibExperimentalPart 3 will compare 2 different long term dosing strategies.
Receives: Drug: Ruxolitinib; Drug: Parsaclisib
Part 4: Ruxolitinib + ParsaclisibExperimentalPart 4 will compare 2 different daily dosing strategies.
Receives: Drug: Ruxolitinib; Drug: Parsaclisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to Day 28

  2. 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.

    Measured: Baseline; Week 12

  3. 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.

    Measured: Baseline; Week 12

Secondary outcomes (29)

  1. 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.

    Measured: Baseline; Week 24

  2. 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.

    Measured: Baseline; Week 24

  3. 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.

    Measured: Baseline; Week 12

  4. 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.

    Measured: Baseline; Week 12

  5. 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.

    Measured: Baseline; Week 24

  6. 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.

    Measured: Baseline; Week 24

  7. 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.

    Measured: Baseline; Week 12

  8. 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.

    Measured: Baseline; Week 12

  9. 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.

    Measured: Baseline; Week 24

  10. 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.

    Measured: Baseline; Week 24

  11. 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."

    Measured: Baseline; up to 1494 days (EOT)

  12. 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."

    Measured: up to 1494 days (EOT)

  13. 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.

    Measured: Week 12 and every 12 weeks thereafter (up to 1494 days [EOT])

  14. 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.

    Measured: up to approximately 4 years

  15. 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.

    Measured: up to approximately 4 years

  16. Cmax of Parsaclisib

    Cmax was defined as the maximum observed plasma concentration.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  17. Tmax of Parsaclisib

    tmax was defined as the time to the maximum concentration.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  18. Cmin of Parsaclisib

    Cmin was defined as the minimum observed plasma concentration.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  19. 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.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  20. 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.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  21. Clast of Parsaclisib

    Clast was defined as the last quantifiable concentration.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  22. Tlast of Parsaclisib

    tlast was defined as the time of the last quantifiable concentration.

    Measured: Week 2 and Week 4: predose and 1, 2, and 4 hours post-dose

  23. Cmax of Ruxolitinib

    Cmax was defined as the maximum observed plasma concentration.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  24. Tmax of Ruxolitinib

    tmax was defined as the time to the maximum concentration.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  25. Cmin of Ruxolitinib

    Cmin was defined as the minimum observed plasma concentration.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  26. 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.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  27. 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.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  28. Clast of Ruxolitinib

    Clast was defined as the last quantifiable concentration.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

  29. Tlast of Ruxolitinib

    tlast was defined as the time of the last quantifiable concentration.

    Measured: Day 1 and Week 4: predose and 1, 2, and 4 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study start8 Feb 2017
  3. Primary completion28 Jan 2021
  4. Study completion29 Apr 2022

Why it stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718300
Sponsor's protocol ID
INCB 50465-201
Other IDs
Parsaclisib
Status last verified
Apr 2024
First submitted
21 Mar 2016
Last updated
1 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Yacoub A, Borate U, Rampal RK, Ali H, Wang ES, Gerds AT, Hobbs G, Kremyanskaya M, Winton E, O'Connell C, Goel S, Oh ST, Schiller G, McCloskey J, Palmer J, Holmes H, Hager S, Assad A, Erickson-Viitanen S, Zhou F, Daver N. Phase 2 study of add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: final results. Blood Adv. 2024 Mar 26;8(6):1515-1528. doi: 10.1182/bloodadvances.2023011620.

    PubMed 38290135

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parsaclisib and Ruxolitinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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