A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma

Official Title

A Phase Ib/II Clinical Study of BBI608 in Combination With Temozolomide for Adult Patients With Recurrent or Progressed Glioblastoma

Summary:

This is an open label, multi-centre, phase 1 safety run-in and phase 2 study of BBI608 in combination with temozolomide in patients with recurrent or progressive glioblastoma who have not received prior bevacizumab therapy.

Trial Description

Primary Outcome:

  • Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs) (Phase 1 portion)
  • Progression Free Survival (PFS)-6 (phase 2 portion)
Secondary Outcome:
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Disease Control Rate (DCR)
  • Objective Response Rate (ORR)
  • Pharmacokinetic profile of BBI608 and temozolomide when administered in combination with temozolomide as assessed by maximum plasma concentration and area under the curve
  • Pharmacodynamic activity of BBI608 when administered in combination with temozolomide as assessed by tumour biopsy and Cancer Stem Cell assays as well as the concentration of study drug in tumours
In arm A, patients who are candidates for surgical resection will receive BBI608 as monotherapy prior to resection, followed by post-operative BBI608 administered in combination with temozolomide. In arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, in combination with temozolomide. In the phase 1/DLT cohort portion of this study, pharmacokinetics will be evaluated for both arms A and B. Pharmacodynamics will be evaluated in all patients who undergo surgical resection.

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