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NCT01556009 · ClinicalTrials.gov registry record · Phase 2

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

A Phase 2 study of Basal Cell Nevus Syndrome and Gorlin's Syndrome, sponsored by UCSF Benioff Children's Hospital Oakland.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
3
Study locations

NCT01556009: Completed Phase 2 study of Basal Cell Nevus Syndrome and Gorlin's Syndrome, sponsored by UCSF Benioff Children's Hospital Oakland.

NCT01556009 is a Phase 2 study of Basal Cell Nevus Syndrome and Gorlin's Syndrome that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01556009, a Phase 2 study of Basal Cell Nevus Syndrome and Gorlin's Syndrome, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

Primary Outcome

Primary: i. To compare the efficacy of (i) intermittent vismodegib vs. (ii) the efficacy of photodynamic therapy (PDT) in preventing the return of the burden of surgically eligible BCCs (SEBs) to baseline level following 7 months of continuous vismodegib therapy. ii. To compare the cumulative diameter (burden) of SEBs in patients treated intermittently with vismodegib vs. with photodynamic therapy (PDT).

Interventions

  • DRUG Vismodegib
  • DRUG Aminolevulinic acid %20 topical solution

Study Locations (3)

California

  • Children's Hospital Oakland Research Institiute - Oakland
  • Children's Hospital Research Center Oakland - Oakland

New York

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2012-04
Est. Completion 2015-12
Phase Phase 2

What the finished NCT01556009 record still lists

NCT01556009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 2 conditions, with Basal Cell Nevus Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Vismodegib is the first listed.

NCT01556009 reports a single indexed study location in California, New York.

Frequently Asked Questions

What is clinical trial NCT01556009 about?

NCT01556009 is a clinical study titled "Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas". The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

What is the current status of trial NCT01556009?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2012-04. Estimated completion is 2015-12.

What conditions does trial NCT01556009 study?

This clinical trial studies the following conditions: Basal Cell Nevus Syndrome, Gorlin's Syndrome.

What interventions are being tested in trial NCT01556009?

The interventions under investigation include: Vismodegib (DRUG), Aminolevulinic acid %20 topical solution (DRUG).

Who is sponsoring clinical trial NCT01556009?

This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01556009 being conducted?

This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01556009's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01556009, the US trial registry maintained by the National Library of Medicine. NCT01556009 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.