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A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
palifermin
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Oncology, KGF, HNC, head and neck, oral mucositis, OM, proteinurea, palifermin, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
  • Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg

Exclusion Criteria:

  • Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
  • Metastatic disease (M1)
  • Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
  • History of pancreatitis
  • Prior radiotherapy to the site of disease
  • Prior chemotherapy or requiring chemotherapy during treatment phase of study
  • Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Palifermin

    Arm Description

    Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.

    Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.

    Outcomes

    Primary Outcome Measures

    Incidence of treatment-emergent proteinuria
    Duration of treatment-emergent proteinuria
    Incidence of chronic proteinuria
    Time (days) to onset of treatment-emergent proteinuria
    Maximum protein-to-creatinine ratio values during the treatment period
    Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time

    Secondary Outcome Measures

    Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
    Disease status at End of Treatment visit
    Incidence of serum anti-palifermin antibody formation
    Incidence of second primary tumors
    Incidence of other malignancies
    Progression-free survival
    Overall survival
    Incidence of adverse events and laboratory abnormalities
    Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4

    Full Information

    First Posted
    October 4, 2007
    Last Updated
    February 27, 2009
    Sponsor
    Swedish Orphan Biovitrum
    Collaborators
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00540332
    Brief Title
    A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
    Official Title
    A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Swedish Orphan Biovitrum
    Collaborators
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    Oncology, KGF, HNC, head and neck, oral mucositis, OM, proteinurea, palifermin, clinical trial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.
    Arm Title
    Palifermin
    Arm Type
    Experimental
    Arm Description
    Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows: PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
    Intervention Type
    Drug
    Intervention Name(s)
    palifermin
    Intervention Description
    120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course
    Primary Outcome Measure Information:
    Title
    Incidence of treatment-emergent proteinuria
    Time Frame
    11 weeks
    Title
    Duration of treatment-emergent proteinuria
    Time Frame
    11 weeks
    Title
    Incidence of chronic proteinuria
    Time Frame
    11 weeks
    Title
    Time (days) to onset of treatment-emergent proteinuria
    Time Frame
    11 weeks
    Title
    Maximum protein-to-creatinine ratio values during the treatment period
    Time Frame
    11 weeks
    Title
    Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time
    Time Frame
    in Week 1
    Secondary Outcome Measure Information:
    Title
    Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
    Time Frame
    11 weeks
    Title
    Disease status at End of Treatment visit
    Time Frame
    11 weeks
    Title
    Incidence of serum anti-palifermin antibody formation
    Time Frame
    11 weeks
    Title
    Incidence of second primary tumors
    Time Frame
    up to 10 years (Long-Term Follow-Up phase)
    Title
    Incidence of other malignancies
    Time Frame
    up to 10 years (Long-Term Follow-Up phase)
    Title
    Progression-free survival
    Time Frame
    up to 10 years (Long-Term Follow-Up phase)
    Title
    Overall survival
    Time Frame
    up to 10 years (Long-Term Follow-Up phase)
    Title
    Incidence of adverse events and laboratory abnormalities
    Time Frame
    11 weeks
    Title
    Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4
    Time Frame
    11 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1) Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg Exclusion Criteria: Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins Metastatic disease (M1) Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years History of pancreatitis Prior radiotherapy to the site of disease Prior chemotherapy or requiring chemotherapy during treatment phase of study Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Biovitrum AB (publ)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

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