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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: Completed Phase 1 study, sponsored by University of Arizona.
NCT02639117 is a Phase 1 study that has completed, run by University of Arizona. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.
Interventions
- DRUG Vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-11-30 |
| Est. Completion | 2017-11-18 |
| Phase | Phase 1 |
What the finished NCT02639117 record still lists
NCT02639117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Vismodegib is the first listed.
NCT02639117 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02639117's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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