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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
NCT04454658 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Navitoclax
- DRUG ABBV-744
Study Locations (20)
New York
- Roswell Park Cancer Institute /ID# 222557 — Buffalo
- The Mount Sinai Hospital /ID# 221549 — New York
- Weill Cornell Medical College /ID# 227069 — New York
Other
- Instituto Nacional de Cancer (INCA) /ID# 226637 — Rio de Janeiro
- Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641 — São Paulo
California
- University of California, Davis Comprehensive Cancer Center /ID# 221790 — Sacramento
New Hampshire
- Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 224623 — Lebanon
Ohio
- Gabrail Cancer Center Research /ID# 222802 — Canton
Oklahoma
- University of Oklahoma, Stephenson Cancer Center /ID# 224095 — Oklahoma City
Oregon
- Oregon Health and Science University /ID# 221801 — Portland
Texas
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004 — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04454658
The ClinicalTrials.gov registry entry for NCT04454658 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelofibrosis (MF) appearing as the primary indexed condition, and to 3 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04454658 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04454658 about?
NCT04454658 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04454658?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2020-11-11. Estimated completion is 2027-01.
What conditions does trial NCT04454658 study?
This clinical trial studies the following conditions: Myelofibrosis (MF). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04454658?
The interventions under investigation include: Ruxolitinib (DRUG), Navitoclax (DRUG), ABBV-744 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04454658?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04454658 being conducted?
This trial has 20 study locations across California, New Hampshire, New York, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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