Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis

Part of paid clinical trials in Stony Brook, New York.

Sponsor
AbbVie
Study ID
NCT04480086
Phase
PHASE1
Status
Terminated

Conditions

  • Myelofibrosis (MF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mivebresib — DRUG
    Tablet: Oral
  • Navitoclax — DRUG
    Tablet; Oral
  • Ruxolitinib — DRUG
    Tablet; Oral

Study Details

Myelofibrosis (MF) is a bone marrow illness that affects blood-forming tissues in the body. MF disturbs the body's normal production of blood cells, causing extensive scarring in the bone marrow. This leads to severe anemia, weakness, fatigue, and an enlarged spleen. The purpose of this study is to see how safe and tolerable mivebresib is, when given alone, and in combination with navitoclax or ruxolitinib, for adult participants with MF. Mivebresib is an investigational drug being developed for the treatment of MF. The study has 4 segments - A, B, C, and D. In Segment A, the safe dosing regimen of mivebresib is identified, and then given alone as monotherapy. In Segment B, C, and D, combination therapies of mivebresib with either ruxolitinib or navitoclax are given. Adult participants with a diagnosis of MF will be enrolled. Around 130 participants will be enrolled in 60 sites worldwide. In Segment A, participants will receive different doses and schedules of oral mivebresib tablet to identify a safe dosing regimen. Additional participants will be enrolled at the identified monotherapy dosing regimen. In Segment B, participants will receive oral ruxolitinib and mivebresib will be given as "add-on" therapy. In Segment C, participants will receive mivebresib and oral navitoclax. In Segment D, participants will receive mivebresib and ruxolitinib. Participants will receive treatment until disease progression or the participants are not able to tolerate the study drugs. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Key Dates

Start date
Mar 17, 2021
Status verified
Aug 2023
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023

Study Design

Enrollment
1 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Segment A: Mivebresib Dose Identification and Optimization
    Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of mivebresib to identify the safe dosing regimen and schedule.
  • Experimental: Segment A: Mivebresib Monotherapy
    Participants will receive the identified safe dosing regimen of mivebresib as monotherapy.
  • Experimental: Segment B: Ruxolitinib + Mivebresib "Add-on" Therapy
    Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and mivebresib as "add-on" therapy.
  • Experimental: Segment C: Mivebresib + Navitoclax
    Participants who have previously been exposed to JAKi, and stopped such therapy, will receive mivebresib and navitoclax.
  • Experimental: Segment D: Mivebresib + Ruxolitinib
    Participants who have never received JAKi will receive mivebresib and ruxolitinib.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Up To Approximately 1 year from start of study ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stony Brook University Hospital /ID# 222653Stony BrookNew York11794-8183-
UC Health - Cincinnati /ID# 224079CincinnatiOhio45267-2800-
Thompson Cancer Survival Ctr /ID# 225802KnoxvilleTennessee37916-
University of Texas MD Anderson Cancer Center /ID# 221652HoustonTexas77030-

Find similar trials in Stony Brook, NY

By research site
Stony Brook University Hospital· Stony Brook, NYUC Health - Cincinnati· Cincinnati, OHThompson Cancer Survival Ctr· Knoxville, TNUniversity of Texas MD Anderson Cancer Center· Houston, TX

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