Enasidenib study

CC-90007-CP-004

A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

Disease:

Acute Myeloid Leukaemia (AML)

Summary:

The bone marrow is like a factory, producing all types of blood cells. This process begins with immature stem cells in the bone marrow, and results in production of mature red cells, platelets and different types of white cells.
Acute myeloid leukaemia (AML) is an aggressive cancer of the bone marrow. In AML, there is an overproduction of immature white cells, known as blasts. These immature cells do not function properly to prevent and fight infection, and can result in production of inadequate numbers of red cells and platelets, which in turn may lead to anaemia, bleeding and bruising.
There are a range of molecular markers that may be mutated in abnormal cells in AML and may affect prognosis. One such marker is IDH-2. This is mutated in around 2-4% of AML.
New drugs targeting molecular mutations are being developed for treatment of AML – including drugs that target mutated IDH-2 (IDH-2 inhibitors).
The aim of this study is to understand the safety and activity of CC-90007, or Enasidenib (an IDH-2 inhibitor) in patients who have AML and who have been shown to have the IDH-2 mutation. The study is also investigating the effect of Enasidenib on the metabolism of compounds and medications that are not part of leukaemia treatment, but may be commonly taken for other medical and non-medical reasons (eg. caffeine, omeprazole, rosuvastatin, midazolam). This is because there is a potential interaction between these compounds and Enasidenib when taken concurrently, and the effect of co-administration has not yet been explored.

Eligibility:

Include, but not limited to, the following:

Include, but not limited to, the following;
- A confirmed diagnosis of AML, including AML that has developed from a background of other bone marrow diseases (eg. myelodysplasia(MDS) or a myeloproloferative neoplasm(MPN))
- Must not have a subtype of AML known as acute promyelocytic leukaemia (APML),
- Must not have a prior history of a chronic form of leukaemia known as CML.
- Evidence of IDH2 mutation in the blood or bone marrow.
- AML in the following settings
- 1) Patients with a relapse of AML having been previously successfully treated, OR
- 2) Patients with AML that has not responded to previous treatment, OR
- 3) Patients who have never received treatment for AML, but in whom standard treatments would be contraindicated, OR
- 4) People who have responded well to initial treatment for AML but in whom the IDH-2 mutation is still detectable at a low level
- No prior therapy with an IDH2 inhibitor, except in particular settings.
- No symptoms of advanced heart failure

Contact person:

Lewis Edwards
Email ledwards@linear.org.au
Phone +61 477 660 142


Email
Phone

Principal Investigator:

Dr Carolyn Grove

Sponsor:

Celgene Corporation

Phase:

I

Protocol Number:

CC-90007-CP-004

Trial Registration Number:

NCT03720366

Clinical Trials.gov

ANZ Clinical Trial Registry