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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Byoung Chul Cho, Yonsei University
ClinicalTrials.gov Identifier:
NCT01449201
First received: October 4, 2011
Last updated: July 2, 2013
Last verified: July 2013

October 4, 2011
July 2, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
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
Response rate [ Time Frame: OCT 2012 [anticipated] ] [ Designated as safety issue: No ]
Tumor assessment by RECIST criteria version 1.1 will be followed at the end of first 28-day treatment, then every 48-day treatment until disease progression Response rate to evaluate the efficacy of PF-00299804 in patients with squamous cell carcinoma of head and neck who failed to platinum-containing treatment.
Complete list of historical versions of study NCT01449201 on ClinicalTrials.gov Archive Site
  • 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
  • Best objective response [ Time Frame: OCT 2012 [anticipated] ] [ Designated as safety issue: No ]
    Tumor assessment by RECIST criteria version 1.1 will be followed at the end of first 28-day treatment, then every 48-day treatment until disease progression
  • Progression-free survival [ Time Frame: APR 2013 [anticipated] ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: APR 2013 [anticipated] ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: OCT 2012 [anticipated] ] [ Designated as safety issue: No ]
    Check every cycle day 1 and every unscheduled visit
  • Predictive biomarker analysis [ Time Frame: APR 2013 [anticipated] ] [ Designated as safety issue: No ]
    EGFR pathway analysis
  • Duration of response [ Time Frame: OCT 2012 [anticipated] ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma
Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Head Neck Cancer Squamous Cell Metastatic
  • Head Neck Cancer Squamous Cell Recurrent
Drug: PF-00299804
45 mg P.O. Daily (28-day treatment as one treatment cycle)
Other Name: PF-00299804
Experimental: PF-00299804
Intervention: Drug: PF-00299804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
October 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01449201
4-2011-0434
No
Byoung Chul Cho, Yonsei University
Yonsei University
Not Provided
Principal Investigator: Byoung Chul Cho, M.D.,Ph.D. Yonsei University
Yonsei University
July 2013

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