Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1

NCT03610022 | Completed Phase 4

• 1 other identifier: CHUBX 2017/41
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Basal Cell Carcinoma; Locally Advanced Basal Cell Carcinoma

Keywords

Vismodegib; Pharmacokinetic; LC-MS/MS-MRM; Human plasma concentrations; Adverse events

Outcome Measures

Primary Outcomes (1)

• Serious side effects (grade 2 or more) during the clinical response follow-up to vismodegib

  Patients already on vismodegib will be monitored at inclusion and for 6 months (M0, M1, M2, M3, M4, M5). New patients will be monitored from the end of the first month after inclusion and during 6 months (M1, M2, M3, M4, M5, M6)

  Occurrence from inclusion to 6 months visit

Secondary Outcomes (2)

• Relationship between the plasma concentrations of free and/or total vismodegib, and covariates

  From inclusion to 6 months visit

• Clinical response to vismodegib in term of efficacy

  at least at each visit, from inclusion to 6 months visit

Study Arms (1)

Patients with BCC and annexial carcinoma

EXPERIMENTAL

Patients with BCC and annexial carcinoma histologically proven under treatment or new patients under vismodegib

Drug: Treatment with vismodegib

Interventions

Treatment with vismodegib DRUG

Vismodegib 150 mg capsules is administered daily with or without food until disease progression or unacceptable toxicity. Patients are followed in the dermatologic unit of Bordeaux University Hospital (Saint André Hospital) every month. At each consultation, clinical and biological datas, and two blood samples are collected just before taking the drug. One sample is for vismodegib quantification (pharmacokinetic protocol), and the other for the determination of alpha-1 glycoprotein acid level

Patients with BCC and annexial carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with BCC and annexial carcinoma histologically proven under treatment or new patients under vismodegib or patients who restarted treatment
• years-old or older
• Complete medical record
• Members or beneficiaries of a social security system,
• Patients must have given informed consent, free and written.

You may not qualify if:

• Patients with or without BCC and not treated with vismodegib
• BCC patients who stopped treatment with vismodegib due to non-response or progression on treatment
• Patients under 18 years-old
• Patients whose medical record is incomplete
• Unaffiliated subjects or not beneficiaries of a security system social,
• Patients who have not been informed and have not given their consent, free and written,
• Pregnant and childbearing women without effective contraceptive method
• Patients with confusional state

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Chu de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Therapeutics; HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 1, 2018
• Study Start: September 3, 2018
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)