XPORT-MF-044
Research type
Research Study
Full title
A PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR MONOTHERAPY IN SUBJECTS WITH JAK INHIBITOR-NAÏVE MYELOFIBROSIS AND MODERATE THROMBOCYTOPENIA.
IRAS ID
1009381
Contact name
Donatella Mastroianni
Contact email
Sponsor organisation
Karyopharm Therapeutics Inc.
Eudract number
2024-511309-47
Clinicaltrials.gov Identifier
Research summary
This study is for patients who have been diagnosed with myelofibrosis (MF) and have never undergone treatment with JAK inhibitors (drugs that help block the growth of cancer cells) for MF.
Cancer is caused by the uncontrolled growth of cells. Normal cells have many ways to regulate growth. These controls are missing or become defective in cancer cells, which is why they can grow without limit. One way cancer cells may continue to grow is by getting rid of certain proteins called tumor suppressor proteins that would normally cause cancer cells to die. Cancer cells can also spread to other parts of the body through the blood and lymph systems. In this way, cancer can invade other tissues and organs.
This study looks at an investigational drug called selinexor that is being developed to treat myelofibrosis (MF).
Selinexor is an experimental drug that is not approved for the treatment of myelofibrosis. The purpose of this research study is to see if selinexor is an effective treatment for MF.It is not known at this time what dose of Selinexor will help treat MF. Selinexor is currently being tested in other clinical trials in patients with cancer, and this study will build on those results. The purpose of this study is to determine the effects, if any, of selinexor on your cancer and on your body, including any side effects.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0417
Date of REC Opinion
8 Jul 2024
REC opinion
Further Information Favourable Opinion