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Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
palbociclib
Cetuximab
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck (SCCHN) focused on measuring palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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.
  • HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays).
  • Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin).
  • Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.

Key Exclusion Criteria:

  • Prior nasopharyngeal cancer, salivary gland or sinus tumors.
  • More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
  • Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.
  • Difficulty swallowing capsules.
  • Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)

Sites / Locations

  • UC San Diego Medical Center - La Jolla (Thornton Hospital)
  • UC San Diego Moores Cancer Center
  • UC San Diego Medical Center- Hillcrest
  • University Medical Center, lnc.:DBA University of Louisville Hospital
  • Mayo Clinic
  • Siteman Cancer Center - West County
  • Barnes-Jewish Hospital
  • Washington University School of Medicine, Siteman Cancer Center
  • Siteman Cancer Center - South County
  • Siteman Cancer Center
  • University of Cincinnati Investigational Pharmacy
  • University of Cincinnati Medical Center
  • UC Health Physicians Office South
  • Henry Joyce Cancer Clinic
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Olomouc, Lekarna
  • Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8
  • Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy
  • Nemocnice Na Bulovce, Ustav radiacni onkologie
  • Debreceni Egyetem klinikai Koezpont Onkologiai Intezet
  • Neuro CT Kft
  • Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi
  • Pecsi Tudomanyegyetem, Klinikai Kozpont,
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont
  • Istituto Nazionale Tumori Napoli
  • Aichi cancer center Central hospital
  • National Cancer Center Hospital East
  • Hokkaido University Hospital/Otolaryngology
  • Shizuoka Cancer Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Instituto Nacional de Cancerologia
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma
  • Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe
  • Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM
  • Oaxaca Site Management Organization S C
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
  • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii
  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii
  • SC Medisprof SRL
  • Centrul de Oncologie Sf. Nectarie SRL
  • SC Oncolab SRL
  • S.C. ONCOCENTER Oncologie Clinica S.R.L.
  • Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala
  • State Budgetary Healthcare Institution of Arkhangelsk Region
  • State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of
  • State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry
  • FSBI "National Medical Scientific Centre of Oncology n.a.N.N.Petrov" of the MOH of Russia
  • Institute for Oncology and Radiology of Serbia
  • Military Medical Academy
  • Narodny onkologicky ustav
  • POKO Poprad, s.r.o.
  • Servicio de Oncologia
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario 12 de Octubre
  • Taichung Veterans General Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Cheng Kung University Hospital Department of Pathology
  • Tri-Service General Hospital
  • Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
  • Communal Institution "Chernivtsi Regional clinical oncology dispensary",
  • SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology
  • CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council
  • Regional Clinical Hospital, Department of microsurgery of otolaryngology organs
  • Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council,
  • Clinic of SI "Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU"
  • Podilskiy Regional Center of Oncology, Chemotherapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palbociclib plus Cetuximab

Placebo plus Cetuximab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever was earlier. Estimates of the PFS curves from the Kaplan Meier method were presented.
Percentage of Participants With Objective Response (OR)
OR was defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate was defined as the proportion of participants with best overall response (BOR) of CR or PR relative to all randomized.
Percentage of Participants With Clinical Benefit Response (CBR)
CBR was defined as the overall CR, PR, or stable disease>=24 weeks according to the RECIST version 1.1. Clinical benefit response rate was defined as the proportion of participants with CR, PR, or stable disease>= 24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline.
Duration of Response (DR)
DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1]/30.4.
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. TEAEs were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Laboratory Abnormalities
The hematology, chemistry and coagulation tests were included in the laboratory examination. Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes. Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate and hemoglobin A1c (HbA1c). Coagulation evaluation included activated partial thromboplastin time/partial thromboplastin time, international normalized ratio (INR) or prothrombin time.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
The EORTC QLQ-H&N35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much"). Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms.Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%)
A central test was defined as the tumor tissue-based p16 IHC test performed at a central laboratory (Ventana). The analysis of concordance between HPV status as assessed by local or central laboratory included the number and percentage of participants with p16 detected or not detected at the central laboratory, given that all local testing must have been negative for HPV in order for the patient to be eligible for the study. Initial analysis of the p16 status was based on the conventional cutoff of 70% p16-positive tumor cells to call out cases that might be considered HPV-positive. P16 expression was scored as positive if strong and diffuse nuclear and cytoplasmic staining was present in at least 70% of the tumor cells.
Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1%
Rb expression in the palbociclib and cetuximab treatment group, the relationship of the biomarker (individually) with PFS and OS were explored using graphical methods such as box plots, at baseline. The tumors of participants were Rb-positive, which was defined by Rb IHC with>=1% positive tumor cells.
Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib
Ctrough is steady-state pre-dose concentration, which was observed directly from data. WPM-Ctrough is within-participant mean steady-state pre-dose concentration. For palbociclib, a steady-state trough was to be defined as a pre-dose plasma concentration following at least 7 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 24 hr +/- 2 hr and 24 min post-dose the day prior to PK collection and no more than 1 hr post-dose on the day of PK collection.
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Ctrough is steady-state pre-dose concentration. Cendinf is steady-state end-of-infusion concentration. Ctrough and Cendinf were observed directly from data. WPM-Ctrough and WPM-Cendinf are within-participant mean steady-state pre-dose concentration and end-of-infusion concentration. Acceptance criteria for a steady-state Cendinf was defined as a PK sample that was 1) collected after at least 3 consecutive weeks of cetuximab IV infusions without interruption or prior dose reduction and 2) was collected at the end of cetuximab infusion time +/- 10% of the actual duration of the cetuximab infusion.

Full Information

First Posted
July 13, 2015
Last Updated
August 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02499120
Brief Title
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2015 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Keywords
palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palbociclib plus Cetuximab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo plus Cetuximab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
palbociclib
Other Intervention Name(s)
IBRANCE, PD-0332991
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
ERBITUX
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
Time Frame
Baseline up to primary completion date (PCD) (about 34 months)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever was earlier. Estimates of the PFS curves from the Kaplan Meier method were presented.
Time Frame
Baseline up to PCD (about 34 months)
Title
Percentage of Participants With Objective Response (OR)
Description
OR was defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate was defined as the proportion of participants with best overall response (BOR) of CR or PR relative to all randomized.
Time Frame
Baseline up to PCD (about 34 months)
Title
Percentage of Participants With Clinical Benefit Response (CBR)
Description
CBR was defined as the overall CR, PR, or stable disease>=24 weeks according to the RECIST version 1.1. Clinical benefit response rate was defined as the proportion of participants with CR, PR, or stable disease>= 24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline.
Time Frame
Baseline up to PCD (about 34 months)
Title
Duration of Response (DR)
Description
DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1]/30.4.
Time Frame
Baseline up to PCD (about 34 months)
Title
Number of Participants With Treatment-Emergent Adverse Events(TEAEs)
Description
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. TEAEs were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame
From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)
Title
Number of Participants With Laboratory Abnormalities
Description
The hematology, chemistry and coagulation tests were included in the laboratory examination. Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes. Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate and hemoglobin A1c (HbA1c). Coagulation evaluation included activated partial thromboplastin time/partial thromboplastin time, international normalized ratio (INR) or prothrombin time.
Time Frame
From the Screening (Day -28) through and including 28 calendar days after the last administration of the study treatment (up to 7 years)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Time Frame
Baseline up to PCD (about 34 months)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)
Description
The EORTC QLQ-H&N35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much"). Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms.Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
Time Frame
Baseline up to PCD (about 34 months)
Title
Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%)
Description
A central test was defined as the tumor tissue-based p16 IHC test performed at a central laboratory (Ventana). The analysis of concordance between HPV status as assessed by local or central laboratory included the number and percentage of participants with p16 detected or not detected at the central laboratory, given that all local testing must have been negative for HPV in order for the patient to be eligible for the study. Initial analysis of the p16 status was based on the conventional cutoff of 70% p16-positive tumor cells to call out cases that might be considered HPV-positive. P16 expression was scored as positive if strong and diffuse nuclear and cytoplasmic staining was present in at least 70% of the tumor cells.
Time Frame
Screening
Title
Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1%
Description
Rb expression in the palbociclib and cetuximab treatment group, the relationship of the biomarker (individually) with PFS and OS were explored using graphical methods such as box plots, at baseline. The tumors of participants were Rb-positive, which was defined by Rb IHC with>=1% positive tumor cells.
Time Frame
Screening
Title
Trough Plasma Concentration (Ctrough) and Within-participant Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib
Description
Ctrough is steady-state pre-dose concentration, which was observed directly from data. WPM-Ctrough is within-participant mean steady-state pre-dose concentration. For palbociclib, a steady-state trough was to be defined as a pre-dose plasma concentration following at least 7 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 24 hr +/- 2 hr and 24 min post-dose the day prior to PK collection and no more than 1 hr post-dose on the day of PK collection.
Time Frame
Pre-dose of Day 15 in Cycle 1 and Cycle 2
Title
Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab
Description
Ctrough is steady-state pre-dose concentration. Cendinf is steady-state end-of-infusion concentration. Ctrough and Cendinf were observed directly from data. WPM-Ctrough and WPM-Cendinf are within-participant mean steady-state pre-dose concentration and end-of-infusion concentration. Acceptance criteria for a steady-state Cendinf was defined as a PK sample that was 1) collected after at least 3 consecutive weeks of cetuximab IV infusions without interruption or prior dose reduction and 2) was collected at the end of cetuximab infusion time +/- 10% of the actual duration of the cetuximab infusion.
Time Frame
Pre-dose and end-of infusion of Day 15 in Cycle 1 and Cycle 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays). Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin). Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation. Key Exclusion Criteria: Prior nasopharyngeal cancer, salivary gland or sinus tumors. More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN. Difficulty swallowing capsules. Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego Medical Center - La Jolla (Thornton Hospital)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UC San Diego Medical Center- Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University Medical Center, lnc.:DBA University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine, Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
University of Cincinnati Investigational Pharmacy
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Physicians Office South
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Henry Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc, Lekarna
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Nemocnice Na Bulovce, Ustav radiacni onkologie
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Debreceni Egyetem klinikai Koezpont Onkologiai Intezet
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Neuro CT Kft
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Klinikai Kozpont,
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Istituto Nazionale Tumori Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Aichi cancer center Central hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hokkaido University Hospital/Otolaryngology
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Instituto Nacional de Cancerologia
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma
City
Oaxaca
State/Province
Oaxaca DE Juarez
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe
City
Oaxaca
State/Province
Oaxaca DE Juarez
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM
City
Oaxaca
State/Province
Oaxaca DE Juarez
ZIP/Postal Code
68120
Country
Mexico
Facility Name
Oaxaca Site Management Organization S C
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36200
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
SC Medisprof SRL
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400058
Country
Romania
Facility Name
Centrul de Oncologie Sf. Nectarie SRL
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
SC Oncolab SRL
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200385
Country
Romania
Facility Name
S.C. ONCOCENTER Oncologie Clinica S.R.L.
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300166
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk Region
City
Arkhangelsk
State/Province
Arkhangelsk Region
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of
City
Sochi
State/Province
Krasnodar Region
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBI "National Medical Scientific Centre of Oncology n.a.N.N.Petrov" of the MOH of Russia
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Institute for Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
POKO Poprad, s.r.o.
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
407
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70154
Country
Taiwan
Facility Name
National Cheng Kung University Hospital Department of Pathology
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
City
Antonivka
State/Province
Kherson Region
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Communal Institution "Chernivtsi Regional clinical oncology dispensary",
City
Chernivtsy
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Regional Clinical Hospital, Department of microsurgery of otolaryngology organs
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council,
City
Kriviy Rig
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Clinic of SI "Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU"
City
Kyiv
ZIP/Postal Code
03057
Country
Ukraine
Facility Name
Podilskiy Regional Center of Oncology, Chemotherapy Department
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
33571736
Citation
Adkins DR, Lin JC, Sacco A, Ley J, Oppelt P, Vanchenko V, Komashko N, Yen CJ, Wise-Draper T, Lopez-Picazo Gonzalez J, Radulovic S, Shen Q, Thurm H, Martini JF, Hoffman J, Huang X, Melichar B, Tahara M. Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-naive, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: A double-blind, randomized, phase 2 trial. Oral Oncol. 2021 Apr;115:105192. doi: 10.1016/j.oraloncology.2021.105192. Epub 2021 Feb 8.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

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