CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
palbociclib +2 moredrug
Likely dose
palbociclib 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02499120
NCT02499120Phase 2Completed
CompareCT.gov

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 2 STUDY OF PALBOCICLIB PLUS CETUXIMAB VERSUS CETUXIMAB FOR THE TREATMENT OF HUMAN PAPILLOMAVIRUS-NEGATIVE, CETUXIMAB-NAÏVE PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AFTER FAILURE OF ONE PRIOR PLATINUM-CONTAINING CHEMOTHERAPY REGIMEN

Pfizer·interventional·Posted Jul 15, 2015·Updated Sep 8, 2023

In Brief

A Phase 2 clinical trial evaluating palbociclib, Cetuximab, and 1 other intervention for Squamous Cell Carcinoma of the Head and Neck (SCCHN). Completed, enrolled 125 participants across 71 sites in 15 countries.

Detailed Summary

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck (SCCHN)
CountriesCzechia, Hungary, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 15, 2015
Enrollment StartSep 10, 2015
Primary CompletionJul 19, 2018
Study CompletionSep 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.0 years ago

Interventions

palbociclibdrug

Palbociclib will be supplied as capsules containing 75 mg, 100 mg, or 125 mg equivalents of palbociclib free base. Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.

Cetuximabdrug

Cetuximab injection for IV infusion will be provided in 100 mg/50 mL, single-use vials, and 200 mg/100 mL, single-use vials. In Japan, cetuximab will be provided in 100 mg/20 mL, single-use vials. Administered, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.

Placebodrug

Placebo for palbociclib will be indistinguishable from the palbociclib capsules and will be supplied as capsules matching in size and color the various palbociclib formulations. Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.