Clinical Trial: To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical S

Brief Summary:

This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).

The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).

The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.


Detailed Summary:

This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).

The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).

The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.

The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.

The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS) and overall survival (OS); to assess the response in terms of overall response rate (ORR) (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)); to assess duration of response (DoR); to assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) ;to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)


Sponsor: Istituto Clinico Humanitas

Current Primary Outcome: evaluate the activity of the study therapy in terms of proportion of patients progression free [ Time Frame: 1 years ]

The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • evaluate the efficacy of the study therapy in terms of progression free survival [ Time Frame: 2 years ]
    The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS)
  • evaluate the efficacy of the study therapy in terms overall survival [ Time Frame: 2 years ]
    The secondary objectives are: to evaluate the efficacy of the study therapy in terms of overall survival (OS);
  • response in terms of overall response rate (ORR) [ Time Frame: 2 years ]
    to assess the response in terms of ORR (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD))
  • duration of response [ Time Frame: 2 years ]
    to assess duration of response (DoR);
  • assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    to assess the safety in terms of incidence, type, and severity of AEs and SAEs
  • measure the effects of skin disease on quality of life (QoL) of patients [ Time Frame: 2 years ]
    to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)


Original Secondary Outcome: Same as current

Information By: Istituto Clinico Humanitas

Dates:
Date Received: July 20, 2016
Date Started: October 2016
Date Completion: November 2019
Last Updated: November 3, 2016
Last Verified: November 2016