Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib
نویسندگان
چکیده
منابع مشابه
Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib.
BACKGROUND Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Administration (FDA) approved for advanced basal cell carcinomas (BCCs) based on a single, nonrandomized, phase-II trial. Consequently, additional clinical data are critical to confirm the efficacy and safety of vismodegib. OBJECTIVE We sought to assess efficacy and safety of vismodegib, while providing e...
متن کاملPharmacokinetic dose-scheduling study of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors.
PURPOSE This study was designed to evaluate whether less frequent dosing [three times per week (TIW) or once weekly (QW)] of 150 mg vismodegib following a loading dose [150 mg once daily (QD) for 11 days] would result in similar safety, tolerability, and steady-state levels of total and unbound vismodegib as continuous QD dosing. EXPERIMENTAL DESIGN Sixty-seven patients with advanced solid tu...
متن کاملVismodegib in the treatment of advanced BCC.
Basal-cell carcinoma (BCC) is the most commonly diagnosed malignancy, comprising over 80 per thousand of non-melanoma skin cancers. Surgical excision is adequate treatment for most BCC's. Options are however limited for the minority of patients presenting with locally advanced inoperable or metastatic BCC. The Hedgehog signalling pathway is a critical driver in the pathogenesis of both sporadic...
متن کاملPhase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors.
PURPOSE The hedgehog (Hh) signaling pathway, a key regulator of cell growth and differentiation during development is implicated in pathogenesis of certain cancers. Vismodegib (GDC-0449) is a small-molecule inhibitor of smoothened, a key component of Hh signaling. This phase I trial assessed GDC-0449 treatment in patients with solid tumors refractory to current therapies or for which no standar...
متن کاملVismodegib: First-in-Class Hedgehog Pathway Inhibitor for Metastatic or Locally Advanced Basal Cell Carcinoma
© 2014 Harborside Press® Skin cancer is the most common cancer type in the United States, affecting more than 3 million people nationally (Cirrone & Harris, 2012). Basal cell carcinoma (BCC) and squamous cell carcinoma are the two main types of nonmelanoma skin cancer, while the more serious form, melanoma, is in its own category. An estimated 80% of nonmelanoma skin cancers are BCCs (Sekulic e...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2012
ISSN: 0923-7534
DOI: 10.1016/s0923-7534(20)33683-8