Trial intelligence / Profile preview

Vismodegib and Radiation for Locally Advanced Head and Neck BCC

NCT01835626Phase 2

Key facts

Status
Completed
Start
May 2013
Primary completion
Sep 2019
Countries
1
Modality
Small Molecules
Conditions
basal cell carcinoma (BCC)
01

Overview

Phase 2, open-label, single-arm trial of vismodegib in basal cell carcinoma (BCC). Primary endpoint: Percentage of Patients With Local-regional Control Rate at 12 months. Started May 2013; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Vismodegib and Radiation Therapy

    Vismodegib induction followed by concurrent Vismodegib and Radiation

03

Who it enrols

Patients with locally advanced BCC of the head and neck, inoperable or medically contraindicated for surgery, with adequate organ function and no distant metastasis.

04

Endpoints

Primary

  • Percentage of Patients With Local-regional Control Rate

Secondary

  • Progression-Free Survival

  • Overall Survival

  • Percentage of Patients by Treatment-Related Adverse Events

  • Number of Patients Discontinuing Treatment Due to Toxicity

  • Clinical Response Rate

  • Percentage of Patients With a Decrease of Basal Cell Carcinoma

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