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

NCT02499120 | Completed Phase 2 Results DMC

• 3 other identifiers: A54810442015-000515-41PALATINUS
• Study Type: interventional
• Target: 125
• Locations: 15 countries
• Sites: 71

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Keywords

palbociclib, cetuximab, human papillomavirus, squamous cell carcinoma, head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to primary completion date (PCD) (about 34 months)

Secondary Outcomes (12)

• Progression Free Survival (PFS)

  Baseline up to PCD (about 34 months)

• Percentage of Participants With Objective Response (OR)

  Baseline up to PCD (about 34 months)

• Percentage of Participants With Clinical Benefit Response (CBR)

  Baseline up to PCD (about 34 months)

• Duration of Response (DR)

  Baseline up to PCD (about 34 months)

• Number of Participants With Treatment-Emergent Adverse Events(TEAEs)

  From the first dose through and including 28 calendar days after the last administration of the study treatment (up to 6.9 years)

Study Arms (2)

Palbociclib plus Cetuximab

EXPERIMENTAL

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.

Drug: palbociclib; Drug: Cetuximab

Placebo plus Cetuximab

ACTIVE COMPARATOR

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.

Drug: Cetuximab; Drug: Placebo

Interventions

palbociclib DRUG

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.

Also known as: IBRANCE, PD-0332991

Palbociclib plus Cetuximab

Cetuximab DRUG

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.

Also known as: ERBITUX

Palbociclib plus Cetuximab; Placebo plus Cetuximab

Placebo DRUG

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.

Placebo plus Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (71)

UC San Diego Medical Center - La Jolla (Thornton Hospital)

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UC San Diego Medical Center- Hillcrest

San Diego, California, 92103, United States

Location

University Medical Center, lnc.:DBA University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States

Location

University of Cincinnati Investigational Pharmacy

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

UC Health Physicians Office South

West Chester, Ohio, 45069, United States

Location

Henry Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice Olomouc, Lekarna

Olomouc, 77520, Czechia

Location

Nemocnice Na Bulovce, Centralni laboratore Pavilon c. 8

Prague, 180 81, Czechia

Location

Nemocnice Na Bulovce, Lekarna, Oddeleni Centralni pripravy

Prague, 180 81, Czechia

Location

Nemocnice Na Bulovce, Ustav radiacni onkologie

Prague, 180 81, Czechia

Location

Debreceni Egyetem klinikai Koezpont Onkologiai Intezet

Debrecen, 4032, Hungary

Location

Neuro CT Kft

Pécs, 7623, Hungary

Location

Pecsi Tudomanyegyetem, Klinikai Kozpont, Laboratoriumi

Pécs, 7624, Hungary

Location

Pecsi Tudomanyegyetem, Klinikai Kozpont,

Pécs, 7624, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet,Onkologiai Kozpont

Szolnok, 5000, Hungary

Location

Istituto Nazionale Tumori Napoli

Napoli, 80131, Italy

Location

Aichi cancer center Central hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital/Otolaryngology

Sapporo, Hokkaido, 060-8648, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Cirugia y Ginecobstetricia de Oaxaca S.A de C.V Hospital Reforma

Oaxaca City, Oaxaca DE Juarez, 68000, Mexico

Location

Diaz San Juan Noe, Imagenologia Siglo XXI San Felipe

Oaxaca City, Oaxaca DE Juarez, 68020, Mexico

Location

Daniel Javier Mendez Lopez Imagen y Diagnostico Medico IDM

Oaxaca City, Oaxaca DE Juarez, 68120, Mexico

Location

Oaxaca Site Management Organization S C

Oaxaca City, 68000, Mexico

Location

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza

Brzozów, 36200, Poland

Location

Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

Gdansk, 80-211, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Oddzial Chemioterapii

Lodz, 93-513, Poland

Location

SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Kliniczny Onkologii

Olsztyn, 10-228, Poland

Location

SC Medisprof SRL

Cluj-Napoca, Cluj, 400058, Romania

Location

Centrul de Oncologie Sf. Nectarie SRL

Craiova, Dolj, 200347, Romania

Location

SC Oncolab SRL

Craiova, Dolj, 200385, Romania

Location

S.C. ONCOCENTER Oncologie Clinica S.R.L.

Timișoara, Timiș County, 300166, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu, Clinica Oncologie Medicala

Sibiu, 550245, Romania

Location

State Budgetary Healthcare Institution of Arkhangelsk Region

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of

Sochi, Krasnodarskiy Kray, 354057, Russia

Location

State Autonomous Healthcare Institution Republican Clinical Oncology Dispensary of the Ministry

Kazan', Tatarstan Republic, 420029, Russia

Location

FSBI "National Medical Scientific Centre of Oncology n.a.N.N.Petrov" of the MOH of Russia

Saint Petersburg, 197758, Russia

Location

Institute for Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Narodny onkologicky ustav

Bratislava, 83310, Slovakia

Location

POKO Poprad, s.r.o.

Poprad, 05801, Slovakia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70154, Taiwan

Location

National Cheng Kung University Hospital Department of Pathology

Tainan, 704, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary

Antonivka, Kherson Oblast, 73000, Ukraine

Location

Communal Institution "Chernivtsi Regional clinical oncology dispensary",

Chernivtsy, 58013, Ukraine

Location

SI Dnipropetrovsk Medical Academy of MoH of Ukraine, Chair of Oncology and Medical Radiology

Dnipropetrovsk, 49044, Ukraine

Location

CI Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council

Dnipropetrovsk, 49102, Ukraine

Location

Regional Clinical Hospital, Department of microsurgery of otolaryngology organs

Ivano-Frankivsk, 76018, Ukraine

Location

Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council,

Kryvyi Rih, 50048, Ukraine

Location

Clinic of SI "Institute of Otolaryngology n.a. Prof. O.S. Kolomyichenka of NAMSU"

Kyiv, 03057, Ukraine

Location

Podilskiy Regional Center of Oncology, Chemotherapy Department

Vinnytsia, 21029, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 33571736 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

palbociclib; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: September 10, 2015
• Primary Completion: July 19, 2018
• Study Completion: September 7, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 20, 2019

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

HU (5); IT (1); UA (8); ES (3); RO (5); SL (2); US (14); TW (5); ME (6); SE (2); KR (3); CZ (5); PL (4); JP (4); RU (4)