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

Head Neck Cancer Squamous Cell Recurrent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449201
• Other study ID #: 4-2011-0434
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2011
• Last updated: September 28, 2014
• Start date: October 2011
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head Neck Cancer Squamous Cell Metastatic
• Head Neck Cancer Squamous Cell Recurrent
• Neoplasms, Squamous Cell

Intervention

Drug:
• PF-00299804
45 mg P.O. Daily (28-day treatment as one treatment cycle)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression	every 8 weeks	No
Secondary	Best objective response	Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression	every 8 weeks	No
Secondary	Progression-free survival	from C1D1 until confirmed disease progression or death	every 8 weeks	No
Secondary	Overall survival	from C1D1 to death	every 12 weeks	No
Secondary	Toxicity profile	from C1D1 to 1 months after the last dose adminitration	every 4 weeks	No