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

NCT01449201 | Completed Phase 2

• 1 other identifier: 4-2011-0434
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 6

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.

Conditions

Head Neck Cancer Squamous Cell Metastatic; Head Neck Cancer Squamous Cell Recurrent

Keywords

PF-00299804, head and neck cancer, squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate

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

  every 8 weeks

Secondary Outcomes (4)

• Best objective response

  every 8 weeks

• Progression-free survival

  every 8 weeks

• Overall survival

  every 12 weeks

• Toxicity profile

  every 4 weeks

Study Arms (1)

PF-00299804

EXPERIMENTAL

Drug: PF-00299804

Interventions

PF-00299804 DRUG

45 mg P.O. Daily (28-day treatment as one treatment cycle)

PF-00299804

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (6)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Chilgok Kyungpook National University Hospital

Daegu, South Korea

Location

Dongsan Medical Center

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital Cancer Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Byoung Chul Cho, M.D.,Ph.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 10, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

KR (6)