- SUB-TYPE OF MDS: Patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome with an IDH1 R132 mutation
- SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
- NAME OF DRUG: FT-2102
- Aims and benefits: FT-2102 is an inhibitor of the mutation IDH1, which is seen in 7-14% of
This is a phase 1/2 study of FT-2102 as a single agent and in combination with azacitidine or low dose cytarabine. The study aims to determine the safety and effectiveness of FT-2102 in this specific patient group.
- Primary outcome measures:
Assessing maximum tolerated dose of the study drug and the rate of complete response.
- Secondary outcome measures:
To determine more information about how the drug works in the body including the rate at which the drug is spread throughout and removed from the bloodstream.
- Main basic inclusion criteria:
- Patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome which is relapsed or refractory to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.
- Patients with an IDH1 R132 mutation
- Good performance status
- Good kidney and liver function
- Main basic exclusion criteria:
- Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
- Heart disease including New York Heart Association Class III or IV heart failure, unstable angina pectoris, previous history of myocardial infarction within 1 year
- Uncontrolled pulmonary disease
- Active uncontrolled infection
- Trial sites/locations and name of physician in charge of trial:
- University College London Hospitals NHS Foundation Trust, LondonKings College Hospital, Brighton
- Royal Marsden Hospital, Sutton
Please read information and always discuss trial information with your own physician.