Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
NCT ID: NCT02499120
Last Updated: 2023-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2015-09-10
2022-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Palbociclib plus Cetuximab
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.
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.
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.
Placebo plus Cetuximab
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UC San Diego Medical Center - La Jolla (Thornton Hospital)
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UC San Diego Medical Center- Hillcrest
San Diego, California, United States
University Medical Center, lnc.:DBA University of Louisville Hospital
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Siteman Cancer Center
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
University of Cincinnati Investigational Pharmacy
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UC Health Physicians Office South
West Chester, Ohio, United States
Henry Joyce Cancer Clinic
Nashville, Tennessee, United States
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Olomouc, Lekarna
Olomouc, , Czechia
Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8
Prague, , Czechia
Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy
Prague, , Czechia
Nemocnice Na Bulovce, Ustav radiacni onkologie
Prague, , Czechia
Debreceni Egyetem klinikai Koezpont Onkologiai Intezet
Debrecen, , Hungary
Neuro CT Kft
Pécs, , Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi
Pécs, , Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont,
Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont
Szolnok, , Hungary
Istituto Nazionale Tumori Napoli
Napoli, , Italy
Aichi cancer center Central hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido University Hospital/Otolaryngology
Sapporo, Hokkaido, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma
Oaxaca City, Oaxaca DE Juarez, Mexico
Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe
Oaxaca City, Oaxaca DE Juarez, Mexico
Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM
Oaxaca City, Oaxaca DE Juarez, Mexico
Oaxaca Site Management Organization S C
Oaxaca City, , Mexico
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza
Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii
Lodz, , Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii
Olsztyn, , Poland
SC Medisprof SRL
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie SRL
Craiova, Dolj, Romania
SC Oncolab SRL
Craiova, Dolj, Romania
S.C. ONCOCENTER Oncologie Clinica S.R.L.
Timișoara, Timiș County, Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala
Sibiu, , Romania
State Budgetary Healthcare Institution of Arkhangelsk Region
Arkhangelsk, Arkhangelskaya oblast, Russia
State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of
Sochi, Krasnodarskiy Kray, Russia
State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry
Kazan', Tatarstan Republic, Russia
FSBI "National Medical Scientific Centre of Oncology n.a.N.N.Petrov" of the MOH of Russia
Saint Petersburg, , Russia
Institute for Oncology and Radiology of Serbia
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Narodny onkologicky ustav
Bratislava, , Slovakia
POKO Poprad, s.r.o.
Poprad, , Slovakia
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Servicio de Oncologia
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Cheng Kung University Hospital Department of Pathology
Tainan City, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
Antonivka, Kherson Oblast, Ukraine
Communal Institution "Chernivtsi Regional clinical oncology dispensary",
Chernivtsy, , Ukraine
SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology
Dnipropetrovsk, , Ukraine
CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, , Ukraine
Regional Clinical Hospital, Department of microsurgery of otolaryngology organs
Ivano-Frankivsk, , Ukraine
Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council,
Kryvyi Rih, , Ukraine
Clinic of SI "Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU"
Kyiv, , Ukraine
Podilskiy Regional Center of Oncology, Chemotherapy Department
Vinnytsia, , Ukraine
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2015-000515-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PALATINUS
Identifier Type: OTHER
Identifier Source: secondary_id
A5481044
Identifier Type: -
Identifier Source: org_study_id
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