To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
Part of paid clinical trials in Berkeley, California.
- Sponsor
- Incyte Corporation
- Study ID
- NCT04551053
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Myelofibrosis
- Post Essential Thrombocythemia Myelofibrosis
- Post Polycythemia Vera Myelofibrosis
- Primary Myelofibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- parsaclisib — DRUGparsaclisib will be administered QD orally
- ruxolitinib — DRUGruxolitinib will be administered BID orally
- placebo — DRUGplacebo will be administered QD orally
Study Details
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.
Key Dates
- Start date
- May 26, 2021
- Status verified
- Sep 2025
- Primary completion
- Aug 16, 2023
- Completion
- Aug 21, 2024
Study Design
- Enrollment
- 177 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group A : ruxolitinib +parsaclisibParticipants 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.
- Placebo Comparator: Group B : ruxolitinib + placeboParticipants 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.
Primary Outcome Measure
Percentage of Participants Achieving ≥25% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging (MRI) (or Computed Tomography [CT] Scan in Applicable Participants) [ Time Frame: Baseline; Week 24 ]
Locations (35)
Find similar trials in Berkeley, CA
By research site
Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center· Berkeley, CACCARE· Fresno, CACalifornia Research Institute (Cri)· Los Angeles, CAEmad Ibrahim Md Inc· Redlands, CAScripps Clinic· San Diego, CACoastal Integrated Cancer Care - Cicc· San Luis Obispo, CA
Related Studies
- SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and RegistryRecruiting · Massive Bio, Inc. · Birmingham, Alabama
- Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) TransplantEARLY_PHASE1 · Recruiting · Omar Aljitawi · Rochester, New York
- A Study of Oral Nuvisertib (TP-3654) in Patients With MyelofibrosisPHASE1/PHASE2 · Recruiting · Sumitomo Pharma America, Inc. · Birmingham, Alabama
- Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative NeoplasmsPHASE2 · Recruiting · University of Washington · Seattle, Washington