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NCT04454658 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Myelofibrosis (MF), sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 20
- Study locations
NCT04454658: Active Phase 1 study of Myelofibrosis (MF), sponsored by AbbVie.
NCT04454658 is a Phase 1 study of Myelofibrosis (MF) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 21 participants, below the 982-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04454658, a Phase 1 study of Myelofibrosis (MF), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
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 |
What the registry record for NCT04454658 still lists
NCT04454658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 982-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (98% lower).
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.
NCT04454658 names 20 study sites across 17 states, led by New York, Other, California.
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).
What interventions are being tested in trial NCT04454658?
The interventions under investigation include: Ruxolitinib (DRUG), Navitoclax (DRUG), ABBV-744 (DRUG).
Who is sponsoring clinical trial NCT04454658?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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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