mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Previously Treated Glioblastoma Multiforme

Official Title

A Phase I/II Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients With Previously Treated Glioblastoma Multiforme

Summary:

The standard or usual treatment for this disease is standard chemotherapy alone. For the first part of this study (phase I), there are two purposes. The first is to see whether AZD2014 can affect glioblastoma multiforme, and the second purpose is to see what effects it has.

Trial Description

Primary Outcome:

  • Recommended phase II dose (RP2D) of AZD2014
  • 6 month progression-free survival rate
Secondary Outcome:
  • Number and severity of adverse events
  • Response rate per RANO criteria
  • T evaluate the plasma levels of AZD2014 alone at the time of resection
In both the phase I & II parts of the study, consenting patients will receive single agent AZD2014 for 2 days immediately prior to surgery (and PK sample) at a fixed dose of 125 mg bid po (i.e. on days -2, -1, and on morning of day 0 [day of surgery]). After recovery from surgery, patients will, within 7-21 days after tumour resection, either start the dose escalation part of the phase I (within 7-21 days after tumour resection) (at the appropriate dose level) or continue on the phase II if the phase II is open. Patients who are unable to proceed to the dose escalation part post resection will be replaced. For this part of the study the purpose is to find the highest dose of AZD2014 that can be tolerated without causing very severe side effects when receiving temozolomide therapy and to see what effects the study drugs have on the participant and their cancer. This is done by starting at a dose lower than the one that investigators know can be given safely to patients when used on its own. Participants are given AZD2014 together with temozolomide and will be watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of AZD2014. Participants joining this study later on will get higher doses of AZD2014 than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by AZD2014. For the second phase of this study (phase II), the purpose is to find out the effects that AZD2014 has on participants and their glioblastoma, using doses found to be safe in the first part of the study, when given with temozolomide.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society