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

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
UC San Diego Medical Center - La Jolla (Thornton Hospital)
La Jolla, California, 92037 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT02499120
Pfizer
Active, not recruiting
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

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Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Intervention  ICMJE
  • 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.
    Other Name: IBRANCE, PD-0332991
  • 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.
    Other Name: ERBITUX
  • 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.

Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: palbociclib
    • Drug: Cetuximab
  • Active Comparator: 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.
    Interventions:
    • Drug: Cetuximab
    • Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 15, 2019)
124
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
120
Estimated Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion DateJuly 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   Ukraine,   United States
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT02499120
Other Study ID Numbers  ICMJE A5481044
2015-000515-41 ( EudraCT Number )
PALATINUS ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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