drugset
drugset / Trial / NCT03389477

Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

NCT03389477 ↗

Phase 2 Active not recruiting 26 enrolled Washington University School of Medicine Pfizer · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.

Timeline

Start
2018-04-27
Primary completion
2022-02-15
Completion
2027-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — —
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Palbociclib Small molecule 125 mg Oral

Indications

head and neck squamous cell carcinoma