Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes (NCT01700049) | Clinical Trial Compass
CompletedPhase 2
Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes
United States28 participantsStarted 2013-01-14
Plain-language summary
The purpose of this study is to investigate the safety and effectiveness of oral vismodegib therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC). The term 'histologic subtype' refers to how the cells and tumor tissue looks under the microscope. Three different 'histologic subtypes' of basal cell skin cancer (infiltrative/morpheaform, nodular and superficial) will be examined in this study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A signed and data informed consent
✓. Willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
✓. 18 years of age or older at time of informed consent
✓. Have one or more clinically suspicious lesions for BCC at Pre-Study screening Visit that has:
✓. a diameter ≥ 6 mm if located on the "mask areas" of face (central face, eyelids, eyebrows, periorbital,nose,lips,chin,mandible,preauricular and postauricular skin/sulci,temple,ear),genitalia,hands,or feet
✓. a diameter ≥ 10 mm if located on cheeks,forehead,scalp,or neck
✓. a diameter ≥ 20 mm if located on trunk and extremities
✓. is ≥ 10 mm,
Exclusion criteria
✕. Women who are pregnant, lactating, or planning pregnancy while in the study
✕. History of prior treatment with vismodegib or any Hh Pathway Inhibitor
✕. Evidence of clinically significant and unstable diseases or conditions; Subjects with clinically stable chronic medical conditions will be allowed to enter the study
✕. Any dermatological disease at treatment site that the investigator thinks may be exacerbated by treatment with vismodegib or cause difficulty with examination
✕. The target lesion identified at Pre-study Screening visit has been determined to be mBCC by radiological assessment prior to first dose of study drug
✕. Inability or unwillingness to swallow capsules
✕. History of infection requiring hospitalization, IV antimicrobial therapy, or is otherwise judged to be clinically significant by the investigator within 4 wks prior to first dose of study drug
✕. History of infection requiring antimicrobial therapy within 2 wks prior to first dose of study drug