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NCT02639117 · ClinicalTrials.gov registry record · Phase 1
Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas
A Phase 1 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02639117 is a Phase 1 study that has completed, run by University of Arizona. The registered enrollment target is 4 participants.
The verdict
NCT02639117, a Phase 1 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a Phase 1 single site study to evaluate the safety and efficacy of a combination therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions with topical application of ALA. The PDT will be first administered at 7+ 4 business days after the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business days. Primary Objective The primary objective of this study is to determine the safety of photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple BCC. 3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study subjects who has complete or partial response to the study treatment.
Interventions
- DRUG Vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-11-30 |
| Est. Completion | 2017-11-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02639117
The ClinicalTrials.gov registry entry for NCT02639117 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vismodegib is the first listed.
NCT02639117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02639117 about?
NCT02639117 is a clinical study titled "Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas". This is a Phase 1 single site study to evaluate the safety and efficacy of a combination therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will receive vismodegib 150mg by ...
What is the current status of trial NCT02639117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2015-11-30. Estimated completion is 2017-11-18.
What interventions are being tested in trial NCT02639117?
The interventions under investigation include: Vismodegib (DRUG).
Who is sponsoring clinical trial NCT02639117?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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