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Bcl-2 Inhibitor

Navitoclax + Ruxolitinib for Myeloproliferative Disorders

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
Navitoclax Monotherapy (Part 1 Only - Japanese Participants):
Must have received ruxolitinib therapy for at least 12 weeks and be currently on a stable dose of ruxolitinib (as described in the protocol).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
Awards & highlights

Study Summary

This trial has 4 parts to evaluate the safety and how well the drug navitoclax works when given alone or with another drug, ruxolitinib. The trial will also look at how navitoclax affects QTc prolongation and how it affects the PK, safety, and tolerability of celecoxib in people with MPN or CMML.

Who is the study for?
This trial is for adults with myeloproliferative disorders who've failed or can't tolerate standard treatments and aren't eligible for stem cell transplantation. They must have stable vital organ functions, an ECOG performance status of <=2 (<=1 in some parts), and specific blood values within range. People with active hepatitis B/C, HIV, recent use of certain drugs affecting coagulation or metabolism, leukemic transformation, or other malignancies within the last 2 years are excluded.Check my eligibility
What is being tested?
The study tests Navitoclax alone and combined with Ruxolitinib to assess safety and how the body processes these drugs in people with myeloproliferative neoplasms. It's divided into five parts: solo Navitoclax effects; its combination with ongoing Ruxolitinib treatment; impact on heart rhythm; interaction with Celecoxib; and a drug-drug interaction assessment followed by extended combination therapy.See study design
What are the potential side effects?
Potential side effects include changes in blood counts leading to increased risk of bleeding or infection, liver function alterations, gastrointestinal symptoms like nausea or diarrhea, fatigue, potential heart rhythm changes (QTc prolongation), as well as possible interactions that could affect how other medications work.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am Japanese and considering Navitoclax treatment (Part 1 only).
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I have been on ruxolitinib for at least 12 weeks and my dose hasn't changed recently.
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My myelofibrosis is classified as intermediate-2 or high-risk.
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I need treatment and have either not responded to or cannot tolerate at least one prior therapy, or I refuse standard therapy.
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I may have had specific treatments for my blood disorder before starting the study drug, but not certain ones right before.
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I am able to get out of my bed or chair and move around.
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My spleen is enlarged, either felt below my ribs or confirmed by a scan.
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I have been diagnosed with a specific type of blood cancer.
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My blood, kidney, liver, and bone marrow are functioning well.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with a type of myelofibrosis according to WHO standards.
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I have been diagnosed with myelofibrosis according to WHO standards.
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I need treatment to reduce blood cells and have not responded well to or cannot tolerate previous treatments.
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I have been diagnosed with myelofibrosis, polycythemia vera, or essential thrombocythemia.
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My blood, kidney, liver, and bone marrow are functioning well.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am eligible for a specific drug combination therapy.
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My blood, kidney, liver, and bone marrow are functioning well.
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I cannot or do not want to have a stem cell transplant.
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I need treatment for myelofibrosis and have either not been treated with a JAK2 inhibitor or have only been treated with ruxolitinib.
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I have tried ruxolitinib for myelofibrosis and it didn't work or caused side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Celecoxib (Part 4)
Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) of Navitoclax
Change in QT interval corrected for heart rate interval by Fridericia's correction formula (QTcF) (Part 3)
+6 more
Secondary outcome measures
Overall Response Rate

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 5: Navitoclax + Ruxolitinib Combination TherapyExperimental Treatment2 Interventions
Participants will receive ruxolitinib BID and navitoclax QD for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.
Group II: Part 4: Navitoclax + CelecoxibExperimental Treatment2 Interventions
Participants will receive navitoclax once daily (QD) starting on Day 3. Participants will also receive celecoxib single dose on Day 1 and Day 7.
Group III: Part 3: Navitoclax MonotherapyExperimental Treatment1 Intervention
Participants will receive navitoclax once daily (QD).
Group IV: Part 2: Navitoclax + Ruxolitinib Combination TherapyExperimental Treatment2 Interventions
Participants will receive various doses of navitoclax once daily (QD) in combination with ruxolitinib twice daily (BID).
Group V: Part 1: Navitoclax MonotherapyExperimental Treatment1 Intervention
Participants will receive various doses of navitoclax once daily (QD).
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
Celecoxib
2019
Completed Phase 4
~1740

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
496,318 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,071 Total Patients Enrolled

Media Library

Navitoclax (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04041050 — Phase 1
Myeloproliferative Neoplasms Research Study Groups: Part 5: Navitoclax + Ruxolitinib Combination Therapy, Part 1: Navitoclax Monotherapy, Part 4: Navitoclax + Celecoxib, Part 3: Navitoclax Monotherapy, Part 2: Navitoclax + Ruxolitinib Combination Therapy
Myeloproliferative Neoplasms Clinical Trial 2023: Navitoclax Highlights & Side Effects. Trial Name: NCT04041050 — Phase 1
Navitoclax (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04041050 — Phase 1

Frequently Asked Questions

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

What potential risks can be attributed to Navitoclax consumption?

"Limited clinical data for both safety and efficacy of Navitoclax resulted in a score of 1 on our scale."

Answered by AI

Are there any vacancies available for those wishing to participate in this clinical trial?

"Per the data found on clinicaltrials.gov, this research is actively seeking participants. The trial was first posted in November of 2019 and has been recently updated as of October 2022."

Answered by AI

What is the participant count of this research project?

"For this research to be successful, 72 patients that meet the eligibility requirements must participate. Such participants can join from two separate locations: St. Joseph Heritage Healthcare /ID# 242558 in Fullerton, California and Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550 in Gettysburg, Pennsylvania."

Answered by AI

What clinical conditions has Navitoclax been approved to address?

"The pharmaceutical Navitoclax has demonstrated efficacy in treating polycythemia vera, polycythemia and those that are resistant or intolerant to hydroxyurea."

Answered by AI

Have any prior investigations explored the potential of Navitoclax as a therapeutic option?

"Presently, there are 141 clinical trials analysing the efficacy of Navitoclax, 18 of which are in the late stages. Though Beijing is home to a significant proportion of these experiments, 4398 sites around the world conduct investigations into this medication."

Answered by AI

How many venues are conducting this experiment?

"Patients can obtain this intervention at St. Joseph Heritage Healthcare/ID# 242558 in Fullerton, California, Pennsylvania Cancer Specialists Research Institute - Gettysburg / ID# 242550 in Gettysburg, Pennsylvania and City of Hope/ ID# 239769in Duarte, Illinois as well as a further 15 clinical trial sites."

Answered by AI
~7 spots leftby Sep 2024