Know Cancer

or
forgot password

Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.


Phase 2
18 Years
75 Years
Not Enrolling
Male
Penile Neoplasms, Carcinoma, Squamous Cell

Thank you

Trial Information

Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.


Inclusion Criteria:



- Patients must provide written informed consent

- Eastern Cooperative Oncology Group performance status of at least 1

- Cytologically or histologically proven diagnosis of SCC of the penis

- Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria

- Clinical stage N2-3 and/or M1 (TNM 2002)

- Locoregional relapse after prior major surgery/ies (either single or multiple)

- No prior systemic therapy except for the administration of
vincristine-bleomycin-methotrexate (VBM) chemotherapy for superficial disease if
administered at least 6 months prior to study enrollment

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

- Central nervous system (CNS) metastases or leptomeningeal carcinomatosis

- History of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary outcome measure will be the assessment of response-rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Outcome Description:

RR (%) = complete response (CR) + partial response (PR), where CR is the disappearance of all target lesions (any pathological lymph-nodes must have reduction in short axis to < 10 mm) and PR indicates at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

Outcome Time Frame:

2-months

Safety Issue:

No

Principal Investigator

Andrea Necchi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori

Authority:

Italy: The Italian Medicines Agency

Study ID:

INT110/12

NCT ID:

NCT01728233

Start Date:

December 2012

Completion Date:

April 2016

Related Keywords:

  • Penile Neoplasms
  • Carcinoma, Squamous Cell
  • Molecular Targeted Therapy
  • Neoadjuvant therapy
  • Dacomitinib
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Penile Neoplasms

Name

Location