Who is sponsoring NCT03610022?

NCT03610022 is sponsored by University Hospital, Bordeaux.

What drugs are being tested in NCT03610022?

Interventions in NCT03610022: Treatment with vismodegib.

What condition does NCT03610022 study?

NCT03610022 studies Metastatic Basal Cell Carcinoma, Locally Advanced Basal Cell Carcinoma.

Is NCT03610022 still recruiting?

NCT03610022 is currently completed. Last updated 18 August 2022.

Last reviewed 2022-08-18 · How we verify

NCT03610022: OPTIVISMO-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1

Completed Phase 4 Last updated 18 August 2022

What this trial tests

Phase 4 trial testing Treatment with vismodegib in Metastatic Basal Cell Carcinoma in 27 participants. Completed in 12 May 2021.

Timeline

3 September 2018

Primary endpoint
12 May 2021

12 May 2021

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	3 September 2018
Primary completion	12 May 2021
Estimated completion	12 May 2021
Sites	1 location across France

Drugs / interventions tested

Treatment with vismodegib — full drug profile →

Conditions studied

Metastatic Basal Cell Carcinoma — all drugs for Metastatic Basal Cell Carcinoma →
Locally Advanced Basal Cell Carcinoma — all drugs for Locally Advanced Basal Cell Carcinoma →

Sponsor

University Hospital, Bordeaux

Who can join

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

Sponsor's own description

Vismodegib (ERIVEDGE®) at the standard dose of 150 mg/day orally is indicated for the treatment of advanced Basal Cell Carcinoma (BCC) and is associated with many adverse effects. Cramps, alopecia, dysgeusia, weight loss and others observed in clinical practice, compromize compliance and often lead to treatment discontinuation. Currently, it is the only drug available in this indication. Our main objective is to assess the relationship between plasma concentrations of vismodegib, and the occurrence of adverse effects within 6 months of inclusion in the study.

Publications & conference data

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

Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
New Insights Into the Role of Phenotypic Plasticity and EMT in Driving Cancer Progression.
Bhatia S, Wang P, Toh A, Thompson EW. · · 2020 · cited 63× · PMID 32391381 · DOI 10.3389/fmolb.2020.00071
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
The Role of Smoothened in Cancer.
Jeng KS, Sheen IS, Leu CM, Tseng PH, et al · · 2020 · cited 47× · PMID 32962123 · DOI 10.3390/ijms21186863
Recent advances in cancer-associated fibroblast: Biomarkers, signaling pathways, and therapeutic opportunities.
Zhou D, Zheng L. · · 2024 · cited 10× · PMID 38420743 · DOI 10.1097/cm9.0000000000003031

Verify or expand the search:

Other recruiting trials for Metastatic Basal Cell Carcinoma

Currently open trials in the same condition.

NCT05896839 — Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metasta · Phase 1, PHASE2 · recruiting
NCT03816332 — Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic · Phase 1 · active not recruiting

Other University Hospital, Bordeaux trials

Trials by the same sponsor.

NCT07506928 — NEURO - Prognostication Using Late Somatosensory Evoked - Potentials · NA · not yet recruiting
NCT07524036 — Impact of a Nursing Educational Consultation on the Patient's Adherence to Their Post-stroke Care Plan. · NA · not yet recruiting
NCT07527494 — Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction · NA · not yet recruiting
NCT07527442 — Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Va · Phase 2 · not yet recruiting
NCT07478523 — FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03610022 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
Last refreshed: 18 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03610022.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing