CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
GDC-0449drug
Likely dose
GDC-0449 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00957229
NCT00957229Phase 2Completed
CompareCT.gov

A Randomized, Phase II Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS)

UCSF Benioff Children's Hospital Oakland·interventional·Posted Aug 12, 2009·Updated Jan 11, 2021

In Brief

A Phase 2 clinical trial evaluating GDC-0449 for Basal Cell Nevus Syndrome and Gorlin Syndrome. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Nevus Syndrome, Gorlin Syndrome
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.9 years ago

Interventions

GDC-0449drug

capsule, 150 mg, one pill daily, 18 months