search
Back to results

PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

Primary Purpose

Head Neck Cancer Squamous Cell Metastatic, Head Neck Cancer Squamous Cell Recurrent

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PF-00299804
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Neck Cancer Squamous Cell Metastatic focused on measuring PF-00299804, head and neck cancer, squamous cell carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of head and neck
  • Age ≥ 18
  • ECOG PS 0-2
  • Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab
  • At least one bidimensionally measurable disease
  • Adequate organ function for treatment
  • Availability of tumor tissue for molecular analysis (archival or rebiopsy tissue)

Exclusion Criteria:

  • Nasopharyngeal carcinoma
  • Eligibility for local therapy (surgery or radiotherapy)
  • Previous treatment with small molecule EGFR tyrosine kinase inhibitors
  • More than one systemic chemotherapy
  • Any major operation or irradiation within 4 weeks of baseline disease assessment
  • Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  • CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
  • Patients with known interstitial lung disease
  • Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
  • Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
  • Pregnant or breast-feeding women
  • Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Sites / Locations

  • Chilgok Kyungpook National University Hospital
  • Dongsan Medical Center
  • Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PF-00299804

Arm Description

Outcomes

Primary Outcome Measures

Response rate
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression

Secondary Outcome Measures

Best objective response
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
Progression-free survival
from C1D1 until confirmed disease progression or death
Overall survival
from C1D1 to death
Toxicity profile
from C1D1 to 1 months after the last dose adminitration

Full Information

First Posted
October 4, 2011
Last Updated
September 28, 2014
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT01449201
Brief Title
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma
Official Title
Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer Squamous Cell Metastatic, Head Neck Cancer Squamous Cell Recurrent
Keywords
PF-00299804, head and neck cancer, squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-00299804
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00299804
Intervention Description
45 mg P.O. Daily (28-day treatment as one treatment cycle)
Primary Outcome Measure Information:
Title
Response rate
Description
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
Time Frame
every 8 weeks
Secondary Outcome Measure Information:
Title
Best objective response
Description
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
Time Frame
every 8 weeks
Title
Progression-free survival
Description
from C1D1 until confirmed disease progression or death
Time Frame
every 8 weeks
Title
Overall survival
Description
from C1D1 to death
Time Frame
every 12 weeks
Title
Toxicity profile
Description
from C1D1 to 1 months after the last dose adminitration
Time Frame
every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of head and neck Age ≥ 18 ECOG PS 0-2 Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab At least one bidimensionally measurable disease Adequate organ function for treatment Availability of tumor tissue for molecular analysis (archival or rebiopsy tissue) Exclusion Criteria: Nasopharyngeal carcinoma Eligibility for local therapy (surgery or radiotherapy) Previous treatment with small molecule EGFR tyrosine kinase inhibitors More than one systemic chemotherapy Any major operation or irradiation within 4 weeks of baseline disease assessment Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment Patients with known interstitial lung disease Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension) Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ) Pregnant or breast-feeding women Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byoung Chul Cho, M.D.,Ph.D.
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chilgok Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital Cancer Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

We'll reach out to this number within 24 hrs