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Trial record 1 of 1 for:    NCT01728233
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Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis (HER-Uro01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728233
Recruitment Status : Unknown
Verified March 2017 by Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : November 19, 2012
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE November 13, 2012
First Posted Date  ICMJE November 19, 2012
Last Update Posted Date March 9, 2017
Actual Study Start Date  ICMJE June 15, 2013
Estimated Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2012)
The primary outcome measure will be the assessment of response-rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: 2-months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2012)
  • To assess the safety and tolerability of the study drug. Incidence, nature and severity of treatment-related adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. [ Time Frame: 2-months ]
  • Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course. [ Time Frame: 2-months or longer. ]
  • Progression-free survival. [ Time Frame: 2-months. ]
  • Overall Survival [ Time Frame: 6-months ]
  • Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language. [ Time Frame: 2-months. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
Official Title  ICMJE Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.
Brief Summary Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily on regional lymph-node involvement. Despite the fact that cure can be obtained in patients with low metastatic load (pN1) by monotherapy, combination therapy is required for more advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not very effective so far and the few chances for cure are solely dependent on multimodality treatment, either with surgery or radiation. Based on the observation that the epidermal growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been investigated with promising early results at Istituto Tumori Milan and University of Texas MD Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor dacomitinib for advanced or metastatic penile SCC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Penile Neoplasms
  • Carcinoma, Squamous Cell
Intervention  ICMJE Drug: Dacomitinib
PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
Other Name: PF-00299804
Study Arms  ICMJE Experimental: Dacomitinib (PF-00299804)
PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
Intervention: Drug: Dacomitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 16, 2012)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2018
Estimated Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01728233
Other Study ID Numbers  ICMJE INT110/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Andrea Necchi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Chair: Roberto Salvioni, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP