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Kinase Inhibitor
Ruxolitinib + Abemaciclib for Myelofibrosis
Phase 1
Recruiting
Led By Raajit Rampal
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 2 years
Awards & highlights
Study Summary
This trial tests a new drug combo to treat a blood disorder. It will check if it's safe & effective.
Who is the study for?
This trial is for adults with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis who haven't responded well to ruxolitinib alone. They should have a life expectancy of at least 24 weeks, be able to swallow pills, and not be pregnant or breastfeeding. Participants must use effective contraception and cannot have used CDK4/6 inhibitors before.Check my eligibility
What is being tested?
The study tests if combining ruxolitinib with abemaciclib safely and effectively treats myelofibrosis. Patients previously treated with ruxolitinib but still having symptoms or an enlarged spleen will receive both drugs to see if their condition improves.See study design
What are the potential side effects?
Possible side effects include risks from the individual drugs: Ruxolitinib may cause dizziness, headache, low blood counts; Abemaciclib can lead to diarrhea, fatigue, nausea. Both could potentially affect liver function and increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with dose-limiting toxicity (DLT)
Secondary outcome measures
overall response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ruxolitinib plus AbemaciclibExperimental Treatment2 Interventions
This will be a phase 1 study with a traditional "3+3" design of combination ruxolitinib (at fixed doses of 10mg BID or 15mg BID) and abemaciclib. There are 3 planned dose levels of abemaciclib: 50, 100 and 150 mg. Cycles will be 4 weeks (28 days) long and DLT window will consist of first cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Abemaciclib
2019
Completed Phase 2
~1710
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,837 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,499 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of ruxolitinib for at least 4 weeks.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am not taking any experimental treatments for myelofibrosis.I am still recovering from major surgery complications.I am using effective birth control methods.My liver is functioning well.My spleen is enlarged and/or I have active symptoms despite taking ruxolitinib.I have not had radiation to my spleen in the last 4 months.I am taking medication that strongly affects liver enzymes and cannot stop.I have been treated with CDK4/6 inhibitors before.I have leukemia that has spread to my brain.I cannot swallow pills or have a condition that affects how my intestines absorb medication.I do not have serious or uncontrolled health conditions.I refuse to receive blood transfusions.I have myelofibrosis and need treatment, with a risk level from intermediate-1 to high.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have recovered from the immediate side effects of my recent cancer treatment.I do not have any ongoing serious infections.My blood tests for hemoglobin, white blood cells, and platelets are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib plus Abemaciclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently accessible to participants?
"Clinicaltrials.gov illustrates that this medical trial is in the recruitment period, with its first posting on January 25th 2023 and most recent edition occurring a day later on 26th of January."
Answered by AI
What can be said about the safety of combining Ruxolitinib and Abemaciclib for people?
"With limited data to establish efficacy and safety, our team has evaluated Ruxolitinib plus Abemaciclib's safety at a score of 1 on the risk scale."
Answered by AI
Are there any medical facilities in this city that are currently hosting the research?
"This clinical trial is taking place in locations such as Memorial Sloan Kettering Monmouth, located in Middletown, along with 6 other sites."
Answered by AI
How many participants have joined the clinical trial thus far?
"Affirmative. Clinicaltrials.gov information corroborates that this medical trial, which initiated on 25th January 2023, is actively searching for volunteers. There are seven different clinical sites looking to enrol a total of 18 patients."
Answered by AI
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