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NCT01529450 · ClinicalTrials.gov registry record · NA
Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors
A NA study, sponsored by Anne Chang.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01529450 is a NA study that has completed, run by Anne Chang. The registered enrollment target is 11 participants.
The verdict
NCT01529450, a NA study, has completed, sponsored by Anne Chang.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma. Primary Objectives: • To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor. Secondary Objectives: * To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment * To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage * To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225
Interventions
- DRUG LDE225
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01529450
The ClinicalTrials.gov registry entry for NCT01529450 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anne Chang, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LDE225 is the first listed.
NCT01529450 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01529450 about?
NCT01529450 is a clinical study titled "Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors". This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma. Primary Objectives: • To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with...
What is the current status of trial NCT01529450?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2012-02. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01529450?
The interventions under investigation include: LDE225 (DRUG).
Who is sponsoring clinical trial NCT01529450?
This trial is sponsored by Anne Chang, which has 5 total clinical trials registered on ClinicalTrials.gov.
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