Treatment with a Pan-HER inhibitor in locally advanced/metastatic squamous cell carcinoma of the penis.

Phase 1

• Conditions: locally advanced/metastatic squamous cell carcinoma of the penis; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003590-25-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-06
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

•Cytologically or histologically proven diagnosis of SCC of the penis.
•Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with unequivocal lymphadenopathy.
•Uni- or bidimensionally measurable disease.
•Clinical stage N2-3 and/or M1 (TNM 2002).
•Locoregional relapse after prior major surgery/ies (either single or multiple).
•Age 18-75.
•Written informed consent.
•ECOG performance status of at least 1.
•Neither prior chemotherapy nor treatment with any targeted agent.
•No use of any investigational agents within 4 weeks of study inclusion.
•Adequate bone marrow, liver and renal function.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Excluded Medical Conditions
•History of any one or more of the following cardiovascular conditions within the past 6 months:
oCardiac angioplasty or stenting.
oMyocardial infarction.
oUnstable angina.
oCoronary artery by-pass graft surgery.
oSymptomatic peripheral vascular disease.
oClass III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
oCardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
oScreening ECG with a QTc>450 msec, congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate < 50 bpm (patients with a pacemaker and heart rate > 50 bpm are eligible).
oUncontrolled hypertension.
•History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
•History of HIV infection or active chronic hepatitis B or C.
•Active clinically serious infections (> grade 2 NCI-CTC version 4.0).
•Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
•History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
•Patients undergoing renal dialysis.
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
•Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
•Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
•Patients unable to swallow oral medications.
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug.

Excluded therapies and medications, previous and concomitant
•Treatment with any of the following anti-cancer therapies:
oradiation therapy, surgery or tumor embolization within 14 days prior to the first dose of PF-299804 OR
ochemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of PF-299804.
•(Palliative radiotherapy will be allowed).
•Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study].
•Prior exposure to study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the activity of Dacomitinib in squamous cell carcinoma of the penis;Secondary Objective: Safety and toxicity;Primary end point(s): Response rate;Timepoint(s) of evaluation of this end point: 2 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of adverse events, overall survival, progression free survival;Timepoint(s) of evaluation of this end point: 2 months