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Monoclonal Antibodies
palbociclib for Squamous Cell Carcinoma
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to pcd (about 34 months)
Awards & highlights
Study Summary
This trial will compare the combination of palbociclib with cetuximab to cetuximab alone in people with HPV-negative, cetuximab-naive recurrent/metastatic squamous cell carcinoma of the head and neck to see if it can prolong overall survival.
Eligible Conditions
- Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to pcd (about 34 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to pcd (about 34 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
+9 moreSide effects data
From 2019 Phase 2 trial • 307 Patients • NCT0229680141%
Fatigue
40%
Hot flush
26%
Arthralgia
21%
Headache
18%
Nausea
14%
Diarrhoea
12%
Breast pain
11%
Myalgia
11%
Hypertension
10%
Constipation
10%
Depression
9%
Pain in extremity
8%
Back pain
8%
Dizziness
7%
Insomnia
7%
Dyspepsia
7%
Contusion
7%
Alanine aminotransferase increased
7%
Upper respiratory tract infection
6%
Blood alkaline phosphatase increased
5%
Urinary tract infection
5%
Procedural pain
4%
Vomiting
4%
Decreased appetite
4%
Dyspnoea
4%
Dry skin
3%
Anaemia
3%
Aspartate aminotransferase increased
3%
Cough
3%
Alopecia
2%
Neutrophil count decreased
2%
Epistaxis
2%
Oropharyngeal pain
2%
Pruritus
2%
Rash
1%
Oral pain
1%
White blood cell count decreased
1%
Skin infection
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: Letrozole
B+D+C Palbociclib + Letrozole Regimen
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Palbociclib plus CetuximabExperimental Treatment2 Interventions
Palbociclib, 125 mg, orally once daily (QD) with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle; in combination with Cetuximab, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.
Group II: Placebo plus CetuximabActive Control2 Interventions
Placebo orally QD with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle; in combination with Cetuximab, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
palbociclib
2020
Completed Phase 2
~1230
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,558 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,088,995 Total Patients Enrolled
Frequently Asked Questions
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