All > Myelofibrosis

ABBV-744 for Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osaka Metropolitan University Hospital /ID# 225502, Osaka-shi, JapanMyelofibrosisABBV-744 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing the safety and tolerability of ABBV-744 in adult participants with myelofibrosis. ABBV-744 will be given alone and in combination with either ruxolitinib or navitoclax.

Eligible Conditions
  • Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Up to Approximately 1 year from start of study

Up To Week 12
Accumulation Ratio Of ABBV-744
Apparent Clearance (CL/F) Of ABBV-744
Apparent Volume Of Distribution (Vd/F) Of ABBV-744
Area Under The Concentration Versus Time Curve (AUC) Of ABBV-744
Area Under The Concentration Versus Time Curve (AUC) Of Navitoclax
Area Under The Concentration Versus Time Curve (AUC) Of Ruxolitinib
Half-Life (t1/2) Of ABBV-744
Maximum Observed Plasma Concentration (Cmax) Of Navitoclax
Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib
Maximum Observed Plasma Concentration (Cmax) of ABBV-744
Time To Cmax (Tmax) Of ABBV-744
Time To Cmax (Tmax) Of Navitoclax
Time To Cmax (Tmax) Of Ruxolitinib
Up To Week 24
Percentage Of Participants Who Achieve Spleen Volume Reduction Of 35% Or Greater (SVR35)
Year 1
Percentage of Participants With Adverse Events
Up to Week 24
Percentage Of Participants With >= 50% Reduction In Total Symptom Score (TSS)
Week 24
Objective Response Rate (ORR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Imetelstat
1
ABBV-927
1
ABBV-382

Trial Design

5 Treatment Groups

Segment A: ABBV-744 Dose Identification and Optimization
1 of 5
Segment D: ABBV-744 + Ruxolitinib
1 of 5
Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy
1 of 5
Segment A: ABBV-744 Monotherapy
1 of 5
Segment C: ABBV-744 + Navitoclax
1 of 5

Experimental Treatment

130 Total Participants · 5 Treatment Groups

Primary Treatment: ABBV-744 · No Placebo Group · Phase 1

Segment A: ABBV-744 Dose Identification and Optimization
Drug
Experimental Group · 1 Intervention: ABBV-744 · Intervention Types: Drug
Segment D: ABBV-744 + RuxolitinibExperimental Group · 2 Interventions: ABBV-744, Ruxolitinib · Intervention Types: Drug, Drug
Segment B: Ruxolitinib + ABBV-744 "Add on" TherapyExperimental Group · 2 Interventions: ABBV-744, Ruxolitinib · Intervention Types: Drug, Drug
Segment A: ABBV-744 Monotherapy
Drug
Experimental Group · 1 Intervention: ABBV-744 · Intervention Types: Drug
Segment C: ABBV-744 + NavitoclaxExperimental Group · 2 Interventions: ABBV-744, Navitoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
Not yet FDA approved
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 1 year from start of study

Who is running the clinical trial?

AbbVieLead Sponsor
849 Previous Clinical Trials
473,056 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
312 Previous Clinical Trials
120,510 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your lab test results show that your bone marrow, kidneys, and liver are working properly according to the study's requirements.
You are able to perform daily activities without assistance or with only slight limitations due to your medical condition.
You have been experiencing symptoms related to myelofibrosis, and have filled out a questionnaire indicating the severity of your symptoms for at least 4 out of 7 days before the start of the study. Your total score on the questionnaire is 10 or higher, or you have at least 2 symptoms with a score of 3 or higher.
You have been diagnosed with a specific type of bone marrow disease called primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocytopenia myelofibrosis by your doctor.
You have a certain level of risk for the disease, as determined by a scoring system. If you have an enlarged spleen, you may still be eligible under certain conditions.
Your spleen is enlarged and measures more than 5 cm below your ribcage or has a volume of more than 450 cubic centimeters. This will be checked using an MRI or CT scan. If you have been taking medication for Myelofibrosis, the measurement will be taken at least 7 days after stopping the medication, and no later than 10 days before starting the treatment.
You have taken Janus Kinase inhibitors (JAKi) in the past but stopped taking them more than 14 days before the start of the study. If you took JAKi and it did not work well for you, you cannot participate in the study.
You are currently taking a medication called ruxolitinib.
If you are taking a medication called ruxolitinib, you must be willing to take a lower dose during the study. You must have been taking the same dose for at least 14 days before starting the study.
You have been taking ruxolitinib for at least 24 weeks, but your disease has not responded well to the treatment.
References

Frequently Asked Questions

Has the efficacy of ABBV-744 been investigated through other medical experiments?

"Since 2002, ABBV-744 has been studied extensively at the National Institutes of Health Clinical Center. 111 studies have already concluded and 103 are still recruiting subjects from locations such as Dallas and Washington D.C." - Anonymous Online Contributor

Unverified Answer

How many hospitals in North America are involved with this clinical research?

"This particular trial is recruiting patients in 12 cities, such as Dallas, Seattle and Worcester. To best minimize travel commitments associated with this study, it is recommended to join the nearest site available to you." - Anonymous Online Contributor

Unverified Answer

What afflictions is ABBV-744 designed to alleviate?

"ABBV-744 is frequently used to manage polycythemia vera. Additionally, it can be prescribed for various other illnesses such as hydroxyurea intolerance/resistance and primary myelofibrosis." - Anonymous Online Contributor

Unverified Answer

How many individuals are partaking in this medical experiment?

"AbbVie, the trial sponsor, is recruiting 130 eligible patients from different sites including Texas Oncology- Baylor Charles A. Sammons Cancer Center/ID# 240004 in Dallas and Washington VA Puget Sound Health Care System /ID# 224208 in Seattle to complete this study." - Anonymous Online Contributor

Unverified Answer

Are participants still being selected for this experiment?

"Affirmative, according to information on clinicaltrials.gov the trial is currently open for enrollment. This study was originally posted on November 11th 2020 and was last modified on October 20th 2022. 130 participants are needed across 12 sites." - Anonymous Online Contributor

Unverified Answer

What is the current regulatory status of ABBV-744?

"There is minimal clinical data currently available for ABBV-744, thus our team at Power assign it a safety rating of 1." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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