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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031200424

Registered date:17/03/2021

A Randomized, Double-Blind, Placebo-Controlled Study of the PI3K delta Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMyelofibrosis, (Primary, Post Essential Thrombocythemia,Post Polycythemia Vera) Myelofibrosis
Date of first enrollment29/06/2021
Target sample size212
Countries of recruitmentU.S.A,Austria,Belgium,China,Finland,France,Germany,Hungary,Israel,Italy,Korea,Norway,Poland,Romania,Russian Federation,Spain,Taiwan,Turkey,United Kingdom,Japan
Study typeInterventional
Intervention(s)Parallel Assignment Group A : parsaclisib + ruxolitinib parsaclisib (INCB050465) will be administered QD orally. ruxolitinib will be administered BID orally. Group B : placebo + ruxolitinib placebo will be administered QD orally. ruxolitinib will be administered BID orally.

Outcome(s)

Primary OutcomeProportion of participants achieving targeted reduction in spleen volume [ Time Frame: Baseline to Week 24 ]
Secondary Outcome1. Proportion of participants who have a targeted reduction in Total Symptom Score (TSS) [ Time Frame: Baseline to Week 24 ] 2. Change in TSS [ Time Frame: Baseline to Week 24 ] 3. Time to the first >= 50% reduction in TSS [ Time Frame: Baseline to Week 24 ] 4. Overall Survival (OS) [ Time Frame: Up to approximately 36 months ] 5. Number of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 36 months ] 6. Time of onset of targeted reduction in spleen volume [ Time Frame: Baseline to Week 108 ] 7. Duration of maintenance of targeted reduction in spleen volume [ Time Frame: Baseline to Week 108 ]

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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.
Exclude 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 (eg, danazol, hydroxyurea) 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.

Related Information

Contact

Public contact
Name Development Operations
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-3-6625-7500
E-mail japan_clinicaltrials@incyte.com
Affiliation Incyte Biosciences Japan G.K.
Scientific contact
Name Eiji Ueda
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-3-6625-7500
E-mail japan_clinicaltrials@incyte.com
Affiliation Incyte Biosciences Japan G.K.