Phase 1 DESoP with Eribulin with relapsed metastatic cancer patients

• Research type

  Research Study

• Full title

  A Phase I Dose Escalation Study of POL6326 with Eribulin in Patients with Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer

• IRAS ID

  146571

• Contact name

  Professor Chris Twelves

• Contact email

  C.J.Twelves@leeds.ac.uk

• Sponsor organisation

  Polyphor Ltd

• Eudract number

  2013-004997-91

• Clinicaltrials.gov Identifier

  NCT01837095

• Research summary

  The objectives of this study are to determine the safety, tolerability and PK of POL6326 in combination with Eribulin in patients with metastatic breast cancer. The study is a phase 1 dose escalation study which will aim to determine the maximum tolerated dose (MTD) of POL6326. The study drug will be administered intravenously in each cycle. There are 6 cycles in total and 4 cohorts planned. It is expected that a minimum of 18 and a maximum of approximately 21 subjects will take part in this study to determine the maximum tolerated dose. The study will be conducted in the USA and in Europe. There are two sites planned for the UK and the duration of the study will last approximately 2 years and 4 months dependant on the subject’s response to treatment and cancer status.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  14/EM/0063

• Date of REC Opinion

  14 Mar 2014

• REC opinion

  Further Information Favourable Opinion