Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours

Official Title

A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

Summary:

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

Trial Description

Primary Outcome:

  • Dose limiting toxicity [DLTs]
  • Safety profile
Secondary Outcome:
  • Apparent total clearance of the drug from plasma at steady state after oral administration [CLss/F]
  • Maximum plasma concentration at steady state [Css,max]
  • Minimum plasma concentration at steady state [Css, min]
  • Time to maximum plasma concentration at steady state [tss,max]
  • Area under the curve at steady state [AUCss]
  • Dose normalised area under the curve at steady state [dose normalised AUCss]
  • Area under the curve at 0-8 hours [AUC(0-8)]
  • Area under the curve from zero up to time t [AUC0-t]
  • Dose normalised maximum plasma concentration at steady state [dose normalised Css,max]
  • ORR as defined by Investigator-assessed RECIST v1.1, INRC or RANO
  • DCR as defined by Investigator-assessed RECIST v1.1, INRC or RANO
  • DoR as defined by Investigator-assessed RECIST v1.1, INRC or RANO
A Phase I open-label, multicentre study to determine the RP2D of olaparib monotherapy in the paediatric population, and to evaluate the safety, tolerability, PK, PDx and preliminary efficacy of olaparib monotherapy in paediatric patients from ≥6 months to <18 years of age at enrolment, with relapsed or refractory solid or primary CNS tumours (excluding lymphoid malignancies) for whom there are no standard treatment options. It is anticipated that eligible patients fulfilling all of the inclusion criteria and none of the exclusion criteria, will include but will not be limited to those with osteosarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma.

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