A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy

Trial Profile

A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2017

At a glance

  • Drugs Alpelisib (Primary) ; Paclitaxel
  • Indications Advanced breast cancer; Head and neck cancer; Solid tumours
  • Focus Adverse reactions
  • Sponsors Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 11 Oct 2016 Results of safety analysis (n=19) presented at the 41st European Society for Medical Oncology Congress.
    • 11 Sep 2016 Status changed from active, no longer recruiting to completed.
    • 16 Aug 2016 Planned End Date changed from 1 Jun 2016 to 1 Aug 2016.
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