Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Public ClinicalTrials.gov record NCT04997902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.
Study identification
- NCT ID
- NCT04997902
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2021
- Primary completion
- Aug 28, 2025
- Completion
- Aug 28, 2025
- Last update posted
- Jun 4, 2026
2021 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Lake Nona DDU (Florida Cancer Specialists) | Orlando | Florida | 32827 | — |
| University of Maryland School of Medicine (Marlene and Stewart Greenebaum Comprehensive Cancer Center) | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University School of Medicine (Sidney Kimmel Comprehensive Cancer Center) | Baltimore | Maryland | 21231 | — |
| Dana-Farber Cancer Institute (Head and Neck Cancer Treatment Center) | Boston | Massachusetts | 02215 | — |
| Washington University, School of Medicine | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UT Southwestern Medical Center (Harold C. Simmons Comprehensive Cancer Center) | Dallas | Texas | 75390 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04997902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04997902 live on ClinicalTrials.gov.