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

Last updated on December 12, 2018

FOR MORE INFORMATION
Study Location
UC San Diego Medical Center - La Jolla (Thornton Hospital)
La Jolla, California, 92037-0845 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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Pfizer Clinical Trials Contact Center

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Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • 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.

  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 21, 2018
March 24, 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Czechia,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   Ukraine,   United States
Czech Republic
 
NCT02499120
A5481044
2015-000515-41 ( EudraCT Number )
PALATINUS ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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