A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
This research study is investigating a new medication called navitoclax. It's being tested on its own and in combination with an existing drug called ruxolitinib. The study focuses on people with certain blood conditions known as myeloproliferative neoplasms. The main goals are to check how safe navitoclax is, if there are any side effects, and how the body processes it. Researchers also want to understand if navitoclax affects how other medicines, like ruxolitinib or celecoxib, work in the body. This is a Phase 1 study, meaning it's an early look at the drug's safety and how the body handles it, rather than primarily testing its effectiveness.
At a glance
What is this study about?
This study is looking into a new medication called navitoclax for people with a group of blood cancers known as myeloproliferative neoplasms. These conditions cause the body to make too many blood cells. The research aims to understand how safe navitoclax is, whether it causes any side effects, and how the body absorbs, processes, and gets rid of the drug. This information is crucial for developing new treatments.
The study has several parts. In some parts, navitoclax is given on its own. In other parts, it's given together with ruxolitinib, a drug already used to treat some myeloproliferative neoplasms. For those already on ruxolitinib, they need to have been taking a steady dose for a while before joining the study. Researchers will also look at how navitoclax affects the heart's electrical activity and examine if it changes how other medications, specifically celecoxib, act in the body.
Understanding how these drugs interact is vital. By carefully studying its safety and how it works in the body, researchers hope to gather important information that could help patients with myeloproliferative neoplasms in the future. It's important to remember this is an early-stage study, focusing mostly on safety, not on whether the drug effectively treats the disease itself at this point.
Key takeaways
- This study is testing a new drug, navitoclax, for blood cancers called myeloproliferative neoplasms.
- It's checking the drug's safety and how the body uses it, alone and with an existing drug (ruxolitinib).
- Participation involves regular visits, medical assessments, and taking study medication.
- Eligibility depends on your specific diagnosis, past treatments, and general health.
- This is an early-stage study (Phase 1), focused on understanding the drug, not primarily its effectiveness.
- You can stop participating at any time.
Who may be eligible?
To join this study, generally, you must be an adult aged 18 or older. Specific requirements depend on which part of the study you might be suitable for. For some parts, you must have a confirmed diagnosis of certain myeloproliferative neoplasms, such as myelofibrosis, polycythemia vera, or essential thrombocythemia. If you have myelofibrosis, you might need to have tried ruxolitinib already and found it didn't work or you couldn't tolerate it. For polycythemia vera or essential thrombocythemia, you may need blood cell-reducing treatment and have tried other therapies or be unable to take them.
If you're considering the part of the study where navitoclax is given with ruxolitinib, you'll need to have been taking ruxolitinib at a stable dose for at least 12 weeks. You would also need to have an enlarged spleen. All participants usually need to have good general health, as shown by various blood tests for your bone marrow, kidneys, and liver function, and generally be able to manage daily activities without too much difficulty.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of myelofibrosis, polycythemia vera, or essential thrombocythemia?
- Have you tried certain previous treatments, or are you unable to take them (if applicable)?
- Are your blood tests for kidneys, liver, and blood count generally within healthy limits?
- If taking ruxolitinib, have you been on a stable dose for at least 12 weeks?
- Can you generally manage your daily activities without significant difficulty?
What does participation involve?
If you take part in this study, you will likely have regular hospital visits for assessments. These will involve blood tests to check your overall health and how your body is handling the study drugs, as well as scans like MRI or CT to measure spleen size if applicable. You will be given either navitoclax alone, or navitoclax together with ruxolitinib or celecoxib, depending on the specific part of the study you are in. Some parts involve taking drugs twice daily, others once daily. Throughout the study, medical staff will closely monitor your health and any side effects. The total duration of participation will vary depending on the study part and your individual response, but there will be ongoing follow-up to ensure your well-being. Detailed information about the schedule of visits and tests will be provided by the study team.
Potential risks and benefits
Locations (42)
- City of Hope /ID# 239769Verified postcodeDuarte, United States
- Providence - St. Jude Medical Center /ID# 242558Verified postcodeFullerton, United States
- Moores Cancer Center at UC San Diego /ID# 229584Verified postcodeLa Jolla, United States
- UCLA /Id# 222784Verified postcodeLos Angeles, United States
- Northwestern University Feinberg School of Medicine /ID# 224203Verified postcodeChicago, United States
- Norton Cancer Institute - St. Matthews /ID# 239300Verified postcodeLouisville, United States
- Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686Verified postcodeDetroit, United States
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554Verified postcodeOmaha, United States
- Duplicate_East Carolina University Brody School of Medicine /ID# 238560Verified postcodeGreenville, United States
- Gabrail Cancer Center Research /ID# 228924Verified postcodeCanton, United States
- Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550Verified postcodeGettysburg, United States
- Virginia Commonwealth University Medical Center Main Hospital /ID# 228169Verified postcodeRichmond, United States
Common questions
What are myeloproliferative neoplasms?
They are a group of rare blood cancers where the body makes too many blood cells in the bone marrow.
What is a Phase 1 study?
This is an early stage of clinical research. The main goal is to check the safety of a new drug and how the body handles it, not yet to see if it cures the disease.
What is ruxolitinib?
Ruxolitinib is an existing medicine used to treat some types of myeloproliferative neoplasms, particularly myelofibrosis.
What does 'stabilized on ruxolitinib' mean?
It means you have been taking ruxolitinib at a consistent dose for at least 12 weeks without changes, and your body is tolerating it well.
Can I stop participating in the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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