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BET Inhibitor

Mivebresib for Myelofibrosis

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year from start of study

Awards & highlights

Study Summary

This trial is studying the safety and tolerability of mivebresib given alone or in combination with navitoclax or ruxolitinib for adult participants with myelofibrosis.

Eligible Conditions

Myelofibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year from start of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year from start of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year from start of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Adverse Events

Secondary outcome measures

Accumulation Ratio of Mivebresib

Apparent Clearance (CL/F) of Mivebresib

Apparent Volume of Distribution (Vd/F) of Mivebresib

+13 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Segment D: Mivebresib + RuxolitinibExperimental Treatment2 Interventions

Participants who have never received JAKi will receive mivebresib and ruxolitinib.

Group II: Segment C: Mivebresib + NavitoclaxExperimental Treatment2 Interventions

Participants who have previously been exposed to JAKi, and stopped such therapy, will receive mivebresib and navitoclax.

Group III: Segment B: Ruxolitinib + Mivebresib "Add-on" TherapyExperimental Treatment2 Interventions

Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and mivebresib as "add-on" therapy.

Group IV: Segment A: Mivebresib MonotherapyExperimental Treatment1 Intervention

Participants will receive the identified safe dosing regimen of mivebresib as monotherapy.

Group V: Segment A: Mivebresib Dose Identification and OptimizationExperimental Treatment1 Intervention

Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of mivebresib to identify the safe dosing regimen and schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Navitoclax

2012

Completed Phase 2

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,104 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,938 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to enroll in this clinical experiment?

"As per the data found on clinicaltrials.gov, this specific trial is no longer actively recruiting patients. It was posted March 17th 2021 and its last edit occured September 21st 2022. Despite that fact, 212 other trials are currently searching for volunteers to participate in research."

Answered by AI

In what locations is this scientific research being conducted?

"This trial is being conducted at 5 clinical locations, such as Thompson Cancer Survival Ctr /ID# 225802 in Knoxville, University of Texas MD Anderson Cancer Center /ID# 221652 in Houston, and Stony Brook University Hospital /ID# 222653. Additionally, two other sites are included but have not been listed here."

Answered by AI

Could you provide information on the other investigations conducted with Mivebresib?

"Mivebresib was first trialled by the National Institutes of Health Clinical Center in 2002, with 111 subsequent studies conducted. Currently, 103 trials are actively recruiting participants, many at locations based out of Knoxville, Tennessee."

Answered by AI

To what extent is the pool of participants growing for this trial?

"Unfortunately, this trial is not currently seeking any study participants. It was first advertised on March 17th 2021 and the last update occurred September 21st 2022. If you are looking for alternate trials to join, there are 109 studies recruiting patients with primary myelofibrosis and 103 studies enlisting individuals affected by Mivebresib."

Answered by AI

To which medical conditions does Mivebresib provide relief?

"Mivebresib is frequently used to manage polycythemia vera and has been proven effective for treating various other conditions, namely hydroxyurea-resistant or -intolerant polycythemia and primary myelofibrosis."

Answered by AI

Are there any adverse effects associated with taking Mivebresib?

"Based on the available information, our team at Power gave Mivebresib a score of 1 due to its status as a Phase 1 trial, meaning there is limited evidence for both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04480086.