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A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

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Roche

Status and phase

Terminated
Phase 2

Conditions

Basal Cell Carcinoma

Treatments

Drug: Vismodegib
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01898598
ML28726

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
  • Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
  • Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion criteria

  • Prior treatment with vismodegib
  • Known hypersensitivity to any of the study drug excipients
  • Any metastatic basal cell carcinoma
  • Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
  • Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
  • Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
  • Recent, current, or planned participation in another experimental drug study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Treatment:
Drug: Placebo
Vismodegib
Experimental group
Description:
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Treatment:
Drug: Vismodegib

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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