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A Phase 1/2 Open-label, Biomarker-defined Cohort Trial to Evaluate the Safety, Determine the Recommended Combination Dosing, and Assess Early Antitumor Activity of Tipifarnib and Alpelisib for the Treatment of Adult Participants Who Have HRAS-overexpressing and/or PIK3CA-mutated and/or - Amplified Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

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Trial Profile

A Phase 1/2 Open-label, Biomarker-defined Cohort Trial to Evaluate the Safety, Determine the Recommended Combination Dosing, and Assess Early Antitumor Activity of Tipifarnib and Alpelisib for the Treatment of Adult Participants Who Have HRAS-overexpressing and/or PIK3CA-mutated and/or - Amplified Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 26 Dec 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Tipifarnib (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Adverse reactions; Biomarker
  • Acronyms KURRENT; KURRENT-HN
  • Sponsors Kura Oncology

Most Recent Events

  • 23 Dec 2025 Primary end-points are updated to replace the previous safety end-point (To determine the recommended dose and regimen and evaluate the safety and tolerability) with 2 new safety primary end-points namely- "DLT" and "Descriptive statistics of Adverse Events (AEs)".
  • 23 Dec 2025 Actual primary completion date is 30 Jul 2025.
  • 23 Dec 2025 Status changed from active, no longer recruiting to completed.

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