A Study Of PF-05212384 In Combination With Other Anti-Tumour Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

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


This study will evaluate PF-05212384 (gedatolisib) 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. The cisplatin combination expansion portion will evaluate the anti tumour activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

Trial Description

Primary Outcome:

  • Number of participants with Dose-limiting toxicities (DLT)
  • Expansion: Objective Tumour Response in mTNBC patients
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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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society