A Phase 1/2 interventional study of Tipifarnib and Alpelisib in HNSCC, sponsored by Kura Oncology, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Kura Oncology, Inc. · Phase 1/2, Interventional, and Treatment
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 45 is close to the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Kura Oncology, Inc. is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adult participants with R/M HNSCC whose tumors harbor PI3KCA (activating) mutations and/or amplifications
Drug: Tipifarnib · Drug: Alpelisib
Adult participants with R/M HNSCC whose tumors have increased HRAS dependency, defined as HRAS overexpression
Drug: Tipifarnib · Drug: Alpelisib
Oral administration
Oral administration
Also known as: BYL719
Dose-limiting toxicity (DLT)
Rate of DLTs evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. A Treatment-Emergent Adverse Event (TEAE) is an AE occurring on or after Cycle 1 Day 1 and within 30 days of the last dose of tipifarnib or alpelisib, whichever is later. Patients with multiple events are counted only once at the highest CTCAE grade.
Time frame: First 28 days (1 cycle) of combination therapy
Descriptive statistics of Adverse Events (AEs)
Descriptive statistics of Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs; AE severity will be assessed per the NCI CTCAE v 5.0. AEs are coded using the MedDRA dictionary version 28.0. A TEAE is an AE occurring on or after Cycle 1 Day 1 and within 30 days of the last dose of tipifarnib or alpelisib, whichever is later. At each level of summation (system organ class, preferred term), a patient reporting more than one adverse event is counted only once.
Time frame: 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
Objective Response Rate (ORR)
Defined as the proportion of participants with best overall response as a confirmed complete response (CR) or confirmed partial response (PR) by RECIST v1.1. Clopper-Pearson 95% confidence intervals are calculated based on binomial distribution.
Time frame: From Cycle 1 Day 1 until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Median duration of response
Defined for participants with confirmed objective response as the time from the first documentation of response to the first documentation of disease progression by RECIST v1.1 or to death due to any cause before new anti-cancer treatment, whichever occurs first. Median is calculated using Kaplan-Meier method. Confidence interval for median is calculated using the Brookmeyer-Crowley method. Minimum and maximum are actual values rather than estimates.
Time frame: From first documentation of response to first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Disease control rate (DCR)
Disease control rate (CR + PR + SD)
Time frame: From Cycle 1 Day 1 until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Median duration of Disease Control
Defined for participants with confirmed objective response as the time in months from the first documentation of response to the first documentation of disease progression by RECIST v1.1 or to death due to any cause before new anti-cancer treatment, whichever occurs first, in patients with confirmed CR/PR
Time frame: From first documentation of response until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Rate of Stable Disease
Time frame: From Cycle 1 Day 1 until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Median duration of Stable Disease (SD)
Defined as durable SD (\>= 12 weeks) by RECIST v1.1
Time frame: From first documentation of response until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 2 years
Cmax of tipifarnib and alpelisib when administered in combination
Maximum observed concentration following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
Tmax of tipifarnib and alpelisib when administered in combination
Time to reach maximum observed concentration following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
AUC(0-last) of tipifarnib and alpelisib when administered in combination
Area under the concentration-time curve from time zero to time of last quantifiable concentration following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
AUC(tau) of tipifarnib and alpelisib when administered in combination
Area under the concentration-time curve during a dosage interval following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
AUC(0-infinity) of tipifarnib and alpelisib when administered in combination
Area under the concentration-time curve from time zero to infinity following single dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
CL/F of tipifarnib and alpelisib when administered in combination
Apparent total clearance of the drug following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
Vd/F of tipifarnib and alpelisib when administered in combination
Apparent volume of distribution following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
Half-life of tipifarnib and alpelisib when administered in combination
Time required for the amount of drug in the body to decrease by half following single dose and multiple dose administration
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
Accumulation ratio of tipifarnib and alpelisib when administered in combination
Defined as the ratio of drug exposure at steady state to exposure following a single dose. For tipifarnib, the accumulation ratio was calculated as the ratio of area under the plasma concentration-time curve over the dosing interval (AUCτ) on Cycle 2 Day 1 (C2D1) to AUC from time zero to 12 hours (AUC₀-12) on Cycle 1 Day 1 (C1D1). For alpelisib, the accumulation ratio was calculated as the ratio of AUCτ on C2D1 to AUC from time zero to 24 hours (AUC₀-24) on C1D1.
Time frame: Blood samples will be collected on day 1 and day 2 of Cycle 1 and Cycle 2, and on day 1 of Cycle 3 through Cycle 6. Each cycle is 28 days.
Progression-free survival (PFS)
Defined as the time in months from C1D1 to the first documentation of disease progression or death due to any cause before new anti-cancer treatment. Median is calculated using Kaplan-Meier method. Confidence interval for median is calculated using the Brookmeyer-Crowley method. Minimum and maximum are actual values rather than estimates.
Time frame: From Cycle 1 Day 1 until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 3 years
Proportion of participants with PFS at 6 months
Proportion of participants alive and without disease progression at 6 months and before new anti-cancer treatment. Survival probability and confidence interval are calculated based on Kaplan-Meier product-limit method and Greenwood's formula.
Time frame: From Cycle 1 Day 1 until first documentation of disease progression, the start of new anti-cancer therapy, or death, whichever occurs first, assessed up to 6 months
Overall Survival (OS)
OS is the time in months from C1D1 to the date of death due to any cause. For patients with no events, OS will be censored at the last known to be alive date. Median is calculated using Kaplan-Meier method. Confidence interval for median is calculated using the Brookmeyer-Crowley method. Minimum and maximum are actual values rather than estimates.
Time frame: From Cycle 1 Day 1 until 3 years of treatment or death from any cause, whichever comes first
Proportion of patients with OS at 12 months
Proportion of participants alive at 12 months. For patients with no events, OS will be censored at the last known to be alive date. Survival probability and confidence interval are calculated based on Kaplan-Meier product-limit method and Greenwood's formula.
Time frame: From Cycle 1 Day 1 until 12 months of treatment or death from any cause, whichever comes first
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Squamous Cell Carcinoma of Head and Neck→
Kura Oncology, Inc.