Eligibility, any sex, with CDKN2A-p16 Positive or HPV Positive Oropharyngeal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quantitative Change in the Sum of Response Evaluation Criteria in Solid Tumors (RECIST) -Primary· Baseline up to 28 days
Measurable index lesions on paired, pre-and post-treatment computed tomography scans (delta change in T) with size treated as a continuous variable. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) is the sum of target lesions have increased by \>=20% and \>=5 mm from nadir; Stable disease (SD) neither sufficient shrinkage to qualify for PR not sufficient
Stable disease
Group
Value
95% CI
Treatment (Alpelisib)
4
Partial response
Group
Value
95% CI
Treatment (Alpelisib)
1
Complete response
Group
Value
95% CI
Treatment (Alpelisib)
0
Progressive disease
Group
Value
95% CI
Treatment (Alpelisib)
0
Non-evaluable
Group
Value
95% CI
Treatment (Alpelisib)
1
Percent Change in Tumor Size (Change in T) in Patients With Genomic PIK3CA Pathway Alteration (PIK3CA Mutation, Amplification, and Fluorescence in Situ Hybridization [FISH] for PTEN Loss)Primary· Baseline up to 28 days
Will compare percent change in tumor size (change in T) in patients with genomic PIK3CA pathway alteration (PIK3CA mutation, amplification, and fluorescence in situ hybridization \[FISH\] for PTEN loss) versus no genomic activation.
Group
Value
95% CI
Treatment (Alpelisib)
7.6
0 – 33.4
Percentage of Participants With Adverse EventsSecondary· Baseline up to 28 days
Will be reported descriptively, including tabulation of toxicities according to National Cancer Institut (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Diarrhea
Group
Value
95% CI
Treatment (Alpelisib)
3
Creatinine Increased
Group
Value
95% CI
Treatment (Alpelisib)
1
Acute Kidney Injury
Group
Value
95% CI
Treatment (Alpelisib)
1
Maculopapular rash
Group
Value
95% CI
Treatment (Alpelisib)
2
Hyperglycemia
Group
Value
95% CI
Treatment (Alpelisib)
2
Surgical ComplicationsSecondary· Baseline up to 28 days
The safety of this window intervention will be reported descriptively, including tabulation of toxicities according to NCI CTCAE v.4.03, surgical complications, and length of hospital stay.
Group
Value
95% CI
Treatment (Alpelisib)
5
Treatment (Alpelisib)
0
Length of Hospital StaySecondary· Baseline up to 28 days
The safety of this window intervention will be reported descriptively, including tabulation of toxicities according to NCI CTCAE v.4.03, surgical complications, and length of hospital stay.
Group
Value
95% CI
Treatment (Alpelisib)
5.8
3 – 9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from each patient from the time of their first treatment with study drug. Subjects received study drug for 10-21 days. At the 4-week follow up visit, adverse drug reactions were followed until return to baseline or stabilization. At the 4 week follow-up visit, only adverse drug reactions were documented..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06997588 — EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediat
· Phase 2
· recruiting
NCT05948943 — Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
· Phase 2, PHASE3
· recruiting
NCT05967286 — Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
· Phase 2
· withdrawn
NCT04967248 — A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced o
· terminated
NCT05646862 — A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Pa
· Phase 3
· active not recruiting
Other University of Arizona trials
Trials by the same sponsor.
NCT04062890 — Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance
· Phase 2
· withdrawn
NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain
· NA
· not yet recruiting
NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
· suspended
NCT06567899 — Mechanistic Underpinnings of Preeclampsia
· not yet recruiting
NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Arizona
Last refreshed: 17 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03601507.