A Phase I/II, Multicentre, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

Official Title

A Phase I/II, Multicentre, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

Summary:

To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l part) of EGF816 and to investigate the anti-tumour activity of EGF816 (Phase II part).

Trial Description

Primary Outcome:

  • Incidence of Dose Limiting Toxicity (DLT) Phase I Part
  • Overall Response Rate (ORR) Phase II Part
Secondary Outcome:
  • Progression-free survival (Phase I & Phase II Parts)
  • Duration of Response (Phase I & II Parts)
  • Plasma concentration vs. time profiles, plasma PK parameters (Phase I Part & Phase II part)
  • Pre- and on-treatment immunohistochemistry of EGFR pathway molecules (prior to PA05)
  • Overall Response Rate (Phase I & II Parts)
  • Disease Control Rate (Phase I & II Parts)
  • Time to Response (Phase I & II Parts)
  • Safety: Incidence and severity of AEs, changes in laboratory values, vital signs & ECGs. Tolerability: Dose interruptions & reductions (Phase I & II Parts)
  • Duration of Response (Phase II Part)
  • Disease Control Rate (Phase II Part)
  • Progression-Free Survival (Phase II Part)
  • Time to Response (Phase II Part)
  • Overall Survival (Phase II Part)

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