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

Study Identifier
M20-248
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Other
  • Study Drug
  • Mivebresib
  • Navitoclax
  • Ruxolitinib
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Stony Brook University Hospital /ID# 222653
    Stony Brook, New York, United States, 11794-8183
    Status
    Not applicable
    Location
    UC Health - Cincinnati /ID# 224079
    Cincinnati, Ohio, United States, 45267-2800
    Status
    Not applicable
    Location
    Thompson Cancer Survival Ctr /ID# 225802
    Knoxville, Tennessee, United States, 37916
    Status
    Not applicable
    Location
    University of Texas MD Anderson Cancer Center /ID# 221652
    Houston, Texas, United States, 77030
    Status
    Not applicable
    Location
    Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 222669
    Johannesburg, Gauteng, South Africa, 2193
    Status
    Not applicable
    Location
    Alberts Cellular Therapy /ID# 222667
    Pretoria, Gauteng, South Africa, 0044
    Status
    Not applicable
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