Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
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Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
45actual
Sites
11
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-07 | actual | When the study began enrolling |
| Primary completion | 2025-08-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-29 | actual | The whole study's end, after follow-up |
| First posted | 2021-08-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HNSCC
Interventions
- Drug: Tipifarnib
- Drug: Alpelisib — also filed as BYL719
Primary outcomes
what the primary-completion date above is the date OFDose-limiting toxicity (DLT)
measured First 28 days (1 cycle) of combination therapy
Descriptive statistics of Adverse Events (AEs)
measured From Cycle 1 Day 1 until 30 days after last trial intervention dose or 30 days after trial completion, whichever comes first, assessed up to 2 years
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