A phase I study of the Human Pharmacokinetics of Elacytarabine

• Research type

  Research Study

• Full title

  A phase I study of the Human Pharmacokinetics of Elacytarabine

• IRAS ID

  58904

• Contact name

  Steven Knapper

• Sponsor organisation

  Clavis Pharma

• Eudract number

  2010-020972-47

• ISRCTN Number

  n/a

• Research summary

  Acute Myeloid Leukaemia (AML) is a group of disorders with an annual incidence of approximately 4 per 100,000. The annual mortality is rate is approximately two thirds of the annual incidence, demonstrating the need for improved treatment. The investigational drug in this study is ??elacytarabine for infusion 7.5mg/mL?. Elacytarabine is a new chemical entity developed as an anticancer agent. It is a fatty acid derivative of the compound ara-C, which is used in the treatment of AML. This is an open label, fixed dose, phase I pharmacokinetic (PK) study designed to evaluate the pharmacokinetics of elacytarabine as well as of the two metabolites ara-C and ara-U. Secondary endpoints are the remission rate and adverse events. Ten evaluable patients with relapsed / refractory AML will be enrolled in total at 3 study centres in the UK. Each patient will receive elacytarabine for infusion 7.5mg/mL at 2000mg/m2 per day on days 1 to 5 of a 3-weekly treatment cycle. It is intended that patients receive 2 cycles of therapy in the absence of unacceptable side effects or significant disease progression. Further cycles may be given if the investigator considers that the patient benefits from the treatment. Patients are to attend study centre visits during baseline (within 14 days before the first elacytarabine dose), treatment and day 14 ñ 2, and day 21 ñ 1. Vital signs, physical examination, adverse events evaluation and safety blood tests will be done at these visits. The PK blood samples will be taken on selected days in the first cycle only. A follow up visit will be performed at a minimum of 30 days after the last elacytarabine dose. Patients who have responded to elacytarabine treatment will be followed for relapse and survival for at least 6 months.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/46

• Date of REC Opinion

  17 Sep 2010

• REC opinion

  Further Information Favourable Opinion