Trials / Completed
CompletedNCT02499120
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | palbociclib | 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. |
| DRUG | Cetuximab | 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. |
| DRUG | Placebo | 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. |
Timeline
- Start date
- 2015-09-10
- Primary completion
- 2018-07-19
- Completion
- 2022-09-07
- First posted
- 2015-07-15
- Last updated
- 2023-09-08
- Results posted
- 2019-09-20
Locations
71 sites across 15 countries: United States, Czechia, Hungary, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT02499120. Inclusion in this directory is not an endorsement.