Clinical Trial Goal
To find out:
- The highest dose of nuvisertib that’s safe to give
- If nuvisertib, alone or with momelotinib or ruxolitinib, is safe and works well to treat myelofibrosis
You may be able to join this trial if you:
- Are 18 years old or older
- Have myelofibrosis that doctors consider intermediate or high risk
- Have been treated with ruxolitinib or fedratinib or a drug that blocks JAK and it didn’t work or are unable to be treated with ruxolitinib or fedratinib. Your doctor can tell you this
- Have an enlarged spleen
- Have not had radiation treatment to the spleen in the last 6 months
- Are not able to get a blood or marrow transplant (BMT). Your doctor can tell you this
- Have not had a BMT in the last 6 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Momelotinib and ruxolitinib are small molecule inhibitors that block JAK1 and JAK2 in certain cells.
Nuvisertib is a small molecule inhibitor that blocks PIM in certain cells.
You'll be placed in 1 of 3 groups:
Nuvisertib is a small molecule inhibitor that blocks PIM in certain cells.
You'll be placed in 1 of 3 groups:
- Group 1 - nuvisertib
- Group 2 - nuvisertib plus momelotinib
- Group 3 - nuvisertib plus ruxolitinib
You’ll get:
- Momelotinib - Group 2 only - A pill that you take by mouth
- Ruxolitinib - Group 3 only - A pill that you take by mouth
- Nuvisertib – A pill that you take by mouth. The dose you’ll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You’ll have scans and/or biopsies to see how well treatment is working. The clinical trial doctors will check your health for 1 year.
The Food and Drug Administration (FDA) has not yet approved nuvisertib.
Contacts
Reyna Bishop, 617-674-6800, reyna.bishop@us.sumitomo-pharma.com
Jordan Simpson, jordan.simpson@us.sumitomo-pharma.com
Locations
Sponsors
lead: Sumitomo Pharma America, Inc.
