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Trial record 13 of 78 for:    vismodegib

Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC) (VISMONEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02667574
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : June 25, 2019
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: ERIVEDGE Phase 2

Detailed Description:

Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance.

The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arm Intervention/treatment
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg per administration (in accordance with the product SmPC). One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance

Primary Outcome Measures :
  1. the change in surgery stages [ Time Frame: Between baseline and maximum 10 months of treatment ]
    comparison of the surgery stages before and after the treatment with Vismodegib according to specific surgery stage table

Secondary Outcome Measures :
  1. Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib [ Time Frame: from 4 to 10 months of treatment ]
  2. Gravity index related to the surgical or functional results (global score) [ Time Frame: At maximum 10 months of treatment ]
  3. Score of the clinical benefits at BOR [ Time Frame: At maximum 10 months of treatment ]
  4. Assessment of treatment toxicity according to NCI-CTC, v4.0 [ Time Frame: 2 months after the surgery and maximum 12 months after the Vismodegib initiation ]
    National Cancer Institute - CommonToxicity Criteria (NCT-CTC) for the recognition and grading severity of adverse effects of chemotherapy

  5. Quality of life assessment by Skindex-16 questionnaire [ Time Frame: At screening, at 3 months, at 6 months of treatment ]
  6. the tumor recurrence rate [ Time Frame: at 3 years of follow-up ]
  7. the cytological response by biopsy [ Time Frame: from 4 to 10 months of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence. According to the HAS recommendations, two zones are taken into consideration:

    • Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and scalp
    • Zones at higher risk of tumor recurrence: nose and periorificial sites of the cephalic extremity
  2. The decision to include the patient in this study should be taken during the Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be considered as an inadequate treatment. (If the radiotherapist is absent during the meeting, his opinion should be documented in the patient's medical record).
  3. Written informed consent
  4. Age ≥ 18 years old
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
  6. At least one histologically confirmed lesion...
  7. Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
  8. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)
  9. Adequate organ function, as evidenced by the following laboratory results:

    • Hemoglobin > 8.5 g/dL
    • Granulocyte count ≥ 1000/μL
    • Platelet count ≥ 75,000/μL
    • Aspartate transaminase (AST ) and alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
  10. Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
  11. Women of childbearing potential must use one highly-effective method of contraception and one barrier method of contraception during treatment and for 24 months after the final dose. Highly-effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, or intra-uterine devices; refer to Appendix 8 for more details). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, and postovulation methods] and withdrawal are not acceptable methods of contraception.).
  12. For male patients with female partners of childbearing potential, agreement top use a condom with spermicide, even after vasectomy, during sexual intercourse with partners while being treated with Vismodegib and for two months after completion of study treatment
  13. For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib
  14. Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib.
  15. Life expectancy > 12 weeks
  16. Patients covered by a Health Insurance System

Exclusion Criteria:

  1. Inability or unwillingness to swallow capsules
  2. Patients with BCC situated out of the head or the neck area
  3. Pregnancy or lactation
  4. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
  5. Chemotherapy within 4 weeks prior to enrollment
  6. Participation in another clinical trial within 4 weeks prior to enrollment
  7. Radiotherapy within 6 months prior to enrolment
  8. Metastatic BCC
  9. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
  10. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications.
  11. Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC).
  12. Patients unable or unwilling to comply with the protocol requirements
  13. Patients in emergency situations
  14. Patients kept in detention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02667574

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CHU de Besançon
Besançon, France, 25030
Hôpital St André
Bordeaux, France, 33075
CH de Boulogne sur mer
Boulogne sur mer, France, 62321
CHU - Hôpital d'Estaing
Clermont-Ferrand, France, 63003
CHU Bocage
Dijon, France, 21079
Clinique de Dermatologie
Lille, France, 59037
Hôpital de la Timone
Marseille, France, 13885
Hôpital Saint Eloi
Montpellier, France, 34295
Hôpital Bichat
Paris, France, 75018
Hôpital Saint-Louis
Paris, France, 75475
CHU Ambroise Paré
Paris, France, 92104
Hôpital Haut-Lévêque
Pessac, France, 33604
Centre hospitalier Lyon Sud
Pierre-benite, France, 69495
Hôpital Robert Debré
Reims, France, 51100
Hôpital Pontchaillou
Rennes, France, 35033
Hôpitaux de Brabois
Vandoeuvre Les Nancy, France, 54500
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Lille
Hoffmann-La Roche
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Principal Investigator: Laurent MORTIER, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT02667574     History of Changes
Other Study ID Numbers: 2013_36
2013-004338-13 ( EudraCT Number )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
basal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell