A Study Of PF-05212384 In Combination With Other Anti-Tumour Agents

Official Title

A Phase 1b Open-label Three-arm Multi-centre Study To Assess The Safety And Tolerability Of Pf-05212384 (pi3k/Mtor Inhibitor) In Combination With Other Anti-tumour Agents

Summary:

This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumours. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination.

Trial Description

Primary Outcome:

  • Number of participants with Dose-limiting toxicities (DLT)
Secondary Outcome:
  • Maximum Observed Plasma Concentration (Cmax)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Gene sequence data
  • QTc interval
  • Objective tumour response
  • Levels of PI3K pathway protein biomarkers

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