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Basal Cell CarcinomaPhase 2NICCINCT03035188

Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma

A Phase 2 study testing Vismodegib in people with Basal Cell Carcinoma, run by SRH Wald-Klinikum Gera GmbH at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery without prior anticancer treatment will be treated with antitumor medication. But since BCC is mainly localized in clearly visible regions of the body, as e.g. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
Vismodegib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
12 sitesGermany
Study dates
Jan 2017to Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient aged ≥ 18 years
  • Able to participate and willing to give written informed consent including consent for photographs prior to performance of study-related procedures and to comply with the study protocol.
  • Patients with at least 1 large (≥ 2 cm in diameter in head/neck region, ≥ 5 cm for trunk/extremities) basal cell carcinoma (BCC), still resectable, but with increased risk for cosmetic disfigurement or functional defects by assessment of the enrolling physician. Patients with large (as defined above) recurrent basal cell carcinoma are also eligible.
  • Patients must be naïve to treatment with vismodegib or other hedgehog pathway inhibitors
  • Local histopathologic confirmation of BCC (3 mm punch biopsy)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
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  • Consent to undergo mapping biopsies upon reaching complete response
  • Adequate hematologic and organ function, defined by the following laboratory results, to be obtained within 7 days prior to registration and prior to first dose of study drug treatment:
  • Absolute neutrophilic count > 1,0 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Hemoglobin ≥ 8,5 g/dL
  • Albumin ≥ 2.5 g/dL
  • Bilirubin ≤ 1.5 x the upper limit of normal (ULN) or within 3 x ULN for patients
  • Aspartate-aminotransferase, Alanine-aminotransferase, and alkaline phosphatase ≤ 3 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Female patients of childbearing potential must agree to always use 2 effective forms of contraception including one highly effective method and a barrier method during treatment with study medication and for 24 months after the final dose. Male patients with partners of childbearing potential must always use a condom (with spermicide, if available), even after a vasectomy, during treatment with study medication and for at least 2 months after the final dose. Breast feeding is likewise not allowed for at least 24 months after completion of study therapy.
  • Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential (including pre-menopausal women with tubal ligation).
  • Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and follow-up as defined by the treatment discontinuation schedule.
  • Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of vismodegib. Because vismodegib has been detected in seminal fluid, in addition for men, agreement not donate sperm during the study or for at least 2 months after discontinuation of therapy
  • Optional: Consent to undergo non-invasive imaging examinations by means of confocal laserscan-microscopy (CLSM) and/or optical coherence tomography (OCT), during and after end of study treatment.

Who cannot join

  • History of prior treatment with vismodegib or any other hedgehog pathway inhibitor.
  • Radiotherapy that involved the field of the target lesion within 6 months prior to registration. Only one radiotherapy of the target lesion performed > 6 months prior to registration is allowed. If a second radiotherapy in this field took place, patient will be excluded.
  • Any metastatic BCC
  • BCC lesion that is considered to be inoperable (e.g. medical contraindication to surgery, suspicion of bone infiltration)
  • Metatypic BCC
  • Known or suspected Gorlin-Goltz syndrome
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  • Uncontrolled medical illness, including advanced malignancies (no activities of the malignancies in the past 3 years), at the discretion of the Investigator
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
  • History (within 6 months prior to registration) or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Any medical or psychological illness or condition preventing adequate consent or ability to comply with the protocol
  • Inability or unwillingness to swallow capsules
  • Inability or unwillingness to comply with study and follow-up procedures
  • Current severe, uncontrolled systemic disease
  • History of malabsorption or other conditions that would interfere with the absorption of the orally applicated study drug
  • Pregnant, lactating, or breast feeding women
  • Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
  • Participation in another clinical study within 28 days before registration or within a time period of five elimination half-lives of the slowest eliminated previously used study drug (whichever is the longest time period).
  • Known or suspected alcohol or drug abuse in the opinion of the investigator
  • Known hypersensitivity reaction to vismodegib or any of the other ingredients of this medicine
  • Treatment with St John's wort (Hypericum perforatum)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Klinikum Augsburg Süd

    Augsburg, 86179

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Elbe Kliniken Stade - Buxtehude GmbH

    Buxtehude, 21614

  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 01307

  • HELIOS Klinikum Erfurt

    Erfurt, 99089

  • SRH Wald-Klinikum Gera GmbH

    Gera, Thuringia, 07548

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Münster

    Münster, 48149

  • Fachklinik Hornheide

    Münster, 48157

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, 06484

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Phase II, Single-armed, Multicenter Trial of Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma

In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery without prior anticancer treatment will be treated with antitumor medication. But since BCC is mainly localized in clearly visible regions of the body, as e.g. the face, there is also a need to reduce scars as a consequence of surgery which will be accomplished by neoadjuvant therapy.

The used medication - vismodegib - displays controllable adverse events and shows a good efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead to minor surgical intervention thus minimising surgical risks and scars for the patients.

Read the detailed description

Patients with resectable BCC will receive neoadjuvant vismodegib therapy for a time period of 12 weeks which applies to the routine use of vismodegib. This period is chosen because within this time side effects are acceptable and response is expected. Tumor examination will be performed monthly to expeditiously identify patients with progressive disease. This will be done by non-invasive imaging techniques thus a further objective of this study is the testing of diagnostic suitability of non-invasive methodology for the evaluation of response status of the patients.

Patients in this clinical trial will be treated with an effective medication which is approved for the therapy of metastatic and locally advanced BCC for a time having been shown to be effective in neoadjuvant setting The same dose as approved for the advanced BCC disease is used, therefore it can be expected that the side effects will be predictable. Furthermore there are no hints in literature that the efficacy of the used medication may be decreased in patients with resectable BCC.

Since the study patients are less sick than those for whom treatment with vismodegib is approved, surgery would be their therapy according to guideline. Thus the risk of vismodegib treatment has to be judged against the greater surgical risk if BCC will be operated directly without prior reduction of tumor lesion. A benefit for the great majority of the patients will be that smaller lesions result in minor scars and better cosmetically outcome of surgery.

Being tested
Vismodegib
Keywords
resectable
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VismodegibDrug

    Also called Erivedge

    1 capsule (150 mg vismodegib) taken once daily for a maximum of 12 weeks.

Study groups in NCT03035188
Study groupRoleWhat they receive
VismodegibExperimentalContinuous once-daily oral dosing of vismodegib at a dosage of 150 mg per administration
Receives: Drug: Vismodegib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) after 12 weeks of treatment with vismodegib

    Rate of patients with CR, PR and SD

    Measured: 12 weeks

  2. Objective and relative (%) reduction of the involved skin surface after 12 weeks of treatment with vismodegib

    Percent change of the BCC area from baseline to end of study therapy

    Measured: 12 weeks

Secondary outcomes (4)

  1. DCR (CR, PR, or SD) after 12 weeks of treatment with vismodegib in the neoadjuvant treatment setting for different basal cell carcinoma histotypes (superficial, scleroderma, nodular, others)

    Measured: 12 weeks

  2. Duration of overall response (DoR)

    Time from documented CR, PR or SD until progression of disease

    Measured: 12 months

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 12 months

  4. Health-related quality of life in patients receiving vismodegib for neoadjuvant treatment of basal cell carcinoma as measured by the Skindex-16 questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2020
  4. Study completionJan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03035188
Sponsor's protocol ID
ADO-EP02 (ML29328)
Acronym
NICCI
Status last verified
Mar 2019
First submitted
26 Dec 2016
Last updated
11 Feb 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lauterbach B, Kakkassery V, Debus D, Heindl LM, Schultz ES. [Advanced periocular basal cell carcinoma-a therapeutic challenge]. Ophthalmologe. 2019 Mar;116(3):273-277. doi: 10.1007/s00347-018-0734-9. German.

    PubMed 29777299

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vismodegib in people with Basal Cell Carcinoma, run by SRH Wald-Klinikum Gera GmbH at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) after 12 weeks of treatment with vismodegib (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03035188, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.

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