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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01449201
• Collaborator: (none)
• Enrollment: 49
• Locations: 6
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 8.2
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head Neck Cancer Squamous Cell Metastatic; Head Neck Cancer Squamous Cell Recurrent	Drug: PF-00299804	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-00299804	Drug: PF-00299804; 45 mg P.O. Daily (28-day treatment as one treatment cycle)

Outcome Measures

Primary Outcome Measures

1. Response rate [every 8 weeks]

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

Secondary Outcome Measures

1. Best objective response [every 8 weeks]

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

2. Progression-free survival [every 8 weeks]

   from C1D1 until confirmed disease progression or death

3. Overall survival [every 12 weeks]

   from C1D1 to death

4. Toxicity profile [every 4 weeks]

   from C1D1 to 1 months after the last dose adminitration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Chilgok Kyungpook National University Hospital	Daegu		Korea, Republic of
2	Dongsan Medical Center	Daegu		Korea, Republic of
3	Severance Hospital	Seoul		Korea, Republic of	120-752
4	Asan Medical Center	Seoul		Korea, Republic of
5	Samsung Medical Center	Seoul		Korea, Republic of
6	Seoul National University Hospital Cancer Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Byoung Chul Cho, M.D.,Ph.D., Yonsei University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Byoung Chul Cho, assistant professor, Yonsei University
• ClinicalTrials.gov Identifier: NCT01449201
• Other Study ID Numbers: 4-2011-0434
• First Posted: Oct 10, 2011
• Last Update Posted: Sep 30, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Byoung Chul Cho, assistant professor, Yonsei University: PF-00299804, head and neck cancer, squamous cell carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell

Study Results

No Results Posted as of Sep 30, 2014