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A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer

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A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Dec 2024

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At a glance

  • Drugs Inavolisib (Primary) ; Fulvestrant; Letrozole; Metformin; Palbociclib; Pertuzumab; Trastuzumab
  • Indications Advanced breast cancer; HER2 negative breast cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Genentech; Roche

    • Most Recent Events

    • 20 Dec 2024 Planned End Date changed from 30 Nov 2024 to 31 Dec 2026.
    • 20 Dec 2024 Planned primary completion date changed from 30 Nov 2024 to 31 Dec 2026.
    • 27 Mar 2024 Status changed from recruiting to active, no longer recruiting.

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