locally advanced/metastatic squamous cell carcinoma of the penis MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Dacomitinib
Product Code: PF00299804
Pharmaceutical Form: Tablet
INN or Proposed INN: Dacomitinib
Current Sponsor code: PF00299804
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Excluded Medical Conditions • History of any one or more of the following cardiovascular conditions within the past 6 months: o Cardiac angioplasty or stenting. o Myocardial infarction. o Unstable angina. o Coronary artery by-pass graft surgery. o Symptomatic peripheral vascular disease. o Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA). o Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted). o Screening 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 are eligible). o Uncontrolled 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: o radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of PF-299804 OR o chemotherapy, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of adverse events, overall survival, progression free survival;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Italy
Contacts
Public ContactTrial Center
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed