Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis

Part of paid clinical trials in Sacramento, California.

Sponsor
AbbVie
Study ID
NCT04454658
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Myelofibrosis (MF)

Eligibility Criteria

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

Interventions

  • ABBV-744 — 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 ABBV-744 is, when given alone, and in combination with ruxolitinib or navitoclax, for adult participants with MF. ABBV-744 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 ABBV-744 is identified and then, given alone as monotherapy. In Segment B, C, and D, combination therapies of ABBV-744 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 ABBV-744 tablet to identify safe dosing regimen. Additional participants will be enrolled at the identified monotherapy dosign regimen. In Segment B, participants will receive oral ruxolitinib and ABBV-744 will be given as "add-on" therapy. In Segment C, participants will receive ABBV-744 and oral navitoclax. In Segment D, participants will receive ABBV-744 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
Nov 11, 2020
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Segment A: ABBV-744 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 ABBV-744 to identify the safe dosing regimen and schedule.
  • Experimental: Segment A: ABBV-744 Monotherapy
    Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy.
  • Experimental: Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy
    Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy.
  • Experimental: Segment C: ABBV-744 + Navitoclax
    Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax.
  • Experimental: Segment D: ABBV-744 + Ruxolitinib
    Participants who have never received JAKi will receive ABBV-744 and ruxolitinib.

Primary Outcome Measure

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

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, Davis Comprehensive Cancer Center /ID# 221790SacramentoCalifornia95817-
Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 224623LebanonNew Hampshire03756-
Roswell Park Cancer Institute /ID# 222557BuffaloNew York14263-
The Mount Sinai Hospital /ID# 221549New YorkNew York10029-
Weill Cornell Medical College /ID# 227069New YorkNew York10065-
Gabrail Cancer Center Research /ID# 222802CantonOhio44718-
University of Oklahoma, Stephenson Cancer Center /ID# 224095Oklahoma CityOklahoma73104-5418-
Oregon Health and Science University /ID# 221801PortlandOregon97239-
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004DallasTexas75246-2003-
VA Puget Sound Health Care System /ID# 224208SeattleWashington98108-1597-

Find similar trials in Sacramento, CA

By research site
University of California, Davis Comprehensive Cancer Center· Sacramento, CADuplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive· Lebanon, NHRoswell Park Cancer Institute· Buffalo, NYThe Mount Sinai Hospital· New York, NYWeill Cornell Medical College· New York, NYGabrail Cancer Center Research· Canton, OH

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