NCT02639117: PDT-Vismo

Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas

Completed Phase 1 Last updated 18 July 2018

What this trial tests

Phase 1 trial testing Vismodegib in Basal Cell Carcinoma in 4 participants. Completed in 18 November 2017.

Timeline

30 November 2015

Primary endpoint
2 November 2016

18 November 2017

Quick facts

Lead sponsor	University of Arizona
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	30 November 2015
Primary completion	2 November 2016
Estimated completion	18 November 2017
Sites	1 location across United States

Drugs / interventions tested

• Vismodegib (vismodegib) — full drug profile →

Conditions studied

• Basal Cell Carcinoma — all drugs for Basal Cell Carcinoma →

Sponsor

University of Arizona

Who can join

18 and older, any sex, with Basal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
   Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022
2. Hedgehog Signaling in Cancer: A Prospective Therapeutic Target for Eradicating Cancer Stem Cells.
   Sari IN, Phi LTH, Jun N, Wijaya YT, et al · · 2018 · cited 155× · PMID 30423843 · DOI 10.3390/cells7110208
3. Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.
   Jain S, Song R, Xie J. · · 2017 · cited 72× · PMID 28352196 · DOI 10.2147/ott.s130910
4. Extracellular matrix stiffness: mechanisms in tumor progression and therapeutic potential in cancer.
   Zhang M, Zhang B. · · 2025 · cited 69× · PMID 40211368 · DOI 10.1186/s40164-025-00647-2
5. Signaling pathways in the regulation of cancer stem cells and associated targeted therapy.
   Manni W, Min W. · · 2022 · cited 52× · PMID 36226253 · DOI 10.1002/mco2.176
6. Targeting the Hedgehog Pathway in Cancer: Current Evidence and Future Perspectives.
   Girardi D, Barrichello A, Fernandes G, Pereira A. · · 2019 · cited 52× · PMID 30759860 · DOI 10.3390/cells8020153
7. The role of Hedgehog and Notch signaling pathway in cancer.
   Xia R, Xu M, Yang J, Ma X. · · 2022 · cited 39× · PMID 36517618 · DOI 10.1186/s43556-022-00099-8
8. Trial watch: an update of clinical advances in photodynamic therapy and its immunoadjuvant properties for cancer treatment.
   Penetra M, Arnaut LG, Gomes-da-Silva LC. · · 2023 · cited 36× · PMID 37346450 · DOI 10.1080/2162402x.2023.2226535