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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Byoung Chul Cho, Yonsei University
ClinicalTrials.gov Identifier:
NCT01449201
First received: October 4, 2011
Last updated: September 28, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Head Neck Cancer Squamous Cell Metastatic
Head Neck Cancer Squamous Cell Recurrent
Drug: PF-00299804
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression


Secondary Outcome Measures:
  • Best objective response [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression

  • Progression-free survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
    from C1D1 until confirmed disease progression or death

  • Overall survival [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
    from C1D1 to death

  • Toxicity profile [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    from C1D1 to 1 months after the last dose adminitration


Enrollment: 49
Study Start Date: October 2011
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00299804 Drug: PF-00299804
45 mg P.O. Daily (28-day treatment as one treatment cycle)
Other Name: PF-00299804

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449201

Locations
Korea, Republic of
Chilgok Kyungpook National University Hospital
Daegu, Korea, Republic of
Dongsan Medical Center
Daegu, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital Cancer Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Byoung Chul Cho, M.D.,Ph.D. Yonsei University
  More Information

No publications provided

Responsible Party: Byoung Chul Cho, assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01449201     History of Changes
Other Study ID Numbers: 4-2011-0434
Study First Received: October 4, 2011
Last Updated: September 28, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
PF-00299804, head and neck cancer, squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2014