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Trial record 1 of 1 for:    NCT02499120
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Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

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ClinicalTrials.gov Identifier: NCT02499120
Recruitment Status : Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 13, 2015
First Posted Date  ICMJE July 15, 2015
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE September 10, 2015
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 12 months) ]
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02499120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Patient-Reported Outcome (PRO) measures, EORTC QLQ-C30, between the treatment arms [ Time Frame: 22 months (estimated length of study) ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
  • Progression-free survival measure of efficacy between the treatment arms [ Time Frame: 22 months (estimated length of study) ]
    The period from study entry until disease progression, death or date of last contact.
  • Correlations between baseline biomarker (eg, p16, Rb) expression in tumor tissue and clinical efficacy in both treatment arms [ Time Frame: 22 months (estimated length of study) ]
    Tumor tissue biomarkers by IHC (p16 and Rb)
  • Steady state trough concentrations for palbociclib, and trough and maximum concentrations for cetuximab in patients with R/M SCCHN [ Time Frame: 22 months (estimated length of study) ]
    Trough concentrations at steady state for palbociclib; trough and maximum concentrations for cetuximab
  • Duration of response measure of efficacy between the treatment arms [ Time Frame: 22 months (estimated length of study) ]
    Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7 (or 30.44 if in months). DR was calculated for the subgroup of participants with a confirmed objective tumor response. DR is usually categorized by the median with its 95% Confidence Interval (CI), range and 25% and 75% percentiles.
  • Objective response measure of efficacy between the treatment arms [ Time Frame: 22 months (estimated length of study) ]
    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 (ORR) is defined as the proportion of patients with CR or PR relative to (1) all randomized patients and (2) randomized patients with measurable disease at baseline. Designation of best response of SD requires the criteria to be met at least 12 weeks after randomization. Patients who do not have on-study radiographic tumor re-evaluation, who receive anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders in the assessment of ORR. Tumor response will be determined from tumor assessment data (where data meet the criteria for CR or PR).
  • Patient-Reported Outcome (PRO) measures, EORTC QLQ-H&N35, between the treatment arms [ Time Frame: 22 months (estimated length of study) ]
    The EORTC QLQ-H&N35 is designed to be used together with the core QLQ-C30. The time frame of the module is ''during the past week,'' and the format is similar to that of the core questionnaire. Items hn 1 to hn30 are scored on four-point Likert-type categorical scales (''not at all,'' ''a little,'' ''quite a bit,'' ''very much''). Items hn31 to hn35 have a ''no/yes'' response format. The scores are transformed into 0-to-100 scales, with a high score implying a high level of symptoms or problems, in the same way as scoring for symptom scales and single items of the QLQ-C30.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Not 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 Date July 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 Countries Czech 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 Committee Yes
U.S. FDA-regulated Product Not 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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP