Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activation

One trial -- IND.222 - A Phase I/II Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme -- was activated on January 13, 2016.

This trial is an open-label, multicentre, phase I/II study of AZD2014 (days 1-2 weekly) in patients with glioblastoma multiforme receiving standard treatment with temozolomide for 5 days q 28 days. Planned sample size is 52 patients.

    The phase I primary objective of the trial is:
  • To determine the recommended phase II dose (RP2D) of AZD2014 in patients receiving standard temozolomide treatment.
Secondary objectives include:
  • To evaluate the plasma levels of AZD2014 alone at the time of resection.
  • To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide
The phase II primary objective is:
  • To estimate the 6 month PFS rate in patients receiving AZD2014 in addition to their standard temozolomide treatment.
Secondary objectives include:
  • To assess the response rate (per RANO criteria).
  • To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide treatment.