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Updated: Feb 5, 2026

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A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced

Jordi Rodon1, Giuseppe Curigliano2, Jean-Pierre Delord3

  • 1Molecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Centro Cellex, 08035, Barcelona, Spain.

Oncotarget
|September 1, 2018
PubMed

Insights

This study found that combining alpelisib with paclitaxel for advanced solid tumors had a challenging safety profile. The maximum tolerated dose of alpelisib was determined to be 150 mg daily alongside paclitaxel.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Phosphatidylinositol 3-kinase (PI3K) pathway activation is linked to paclitaxel resistance in solid tumors.
  • This study investigated alpelisib, a PI3K p110α inhibitor, combined with paclitaxel.

Purpose of the Study:

  • To assess the safety and activity of alpelisib plus paclitaxel in advanced solid tumors.
  • To determine the maximum tolerated dose (MTD) and recommended Phase II dose of the combination therapy.

Main Methods:

  • A Phase Ib, multicenter, open-label, dose-finding study (NCT02051751).
  • 19 patients with advanced solid tumors received alpelisib (150-300 mg QD) plus paclitaxel (80 mg/m²).
  • Dose-limiting toxicities were monitored to establish the MTD.

Main Results:

  • The MTD of alpelisib with paclitaxel was established as 150 mg QD.
  • Common adverse events included diarrhea (73.7%) and hyperglycemia (57.9%), with significant Grade 3/4 events.
  • Dose-limiting toxicities, primarily hyperglycemia and leukopenia, were observed.

Conclusions:

  • The combination of alpelisib and paclitaxel demonstrated a challenging safety profile in patients with advanced solid tumors.
  • The planned dose-expansion phase was not initiated due to safety findings.
  • Further investigation into this combination may require significant safety modifications.
Keywords:
PIK3CA proteinbreast neoplasmschemotherapydrug resistancehuman

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