Save

A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

PHASE2RECRUITING

In this study, patients with BCC will be given neoadjuvant treatment with a drug called sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by surgery or that has spread through the body. The study aims to see if sonidegib given for 12 weeks will reduce the size of tumours so surgery results in less scarring or may be avoided, with only short term topical treatment required to treat remaining tumour.

Simpliy with AI

Study details:

Surgery is the first line treatment for most basal cell carcinomas (BCCs) with cure rates of 88 to 96%. However, excision of large lesions in sensitive locations such as the face and scalp may result in disfigurement and impairment of function. Neoadjuvant drug treatment given before surgery aims to reduce tumour size so that surgery and recovery is easier.

This approach may also reduce the risk of recurrence. To assess response to treatment, we will use a new technology for skin tumours called optical coherence technology (OCT). This is like an ultrasound scan and is non invasive.

OCT can detect the extent and nature of the tumour and build a 3D image with great accuracy. OCT will be used together with pathological analysis of tumour tissue to determine response to sonidegib.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

≥18 years of age.

Written informed consent.

Histologically confirmed, resectable, invasive basal cell carcinoma.

Site and size of BCC considered to be in a cosmetically challenging position for surgery.

Patient has expressed concerns of the cosmetic outcome of surgery.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Ability to swallow and retain oral medication.

Anticipated life expectancy of > 12 months.

Adequate organ function as demonstrated by blood tests.

Willing to abstain from blood donations for 20 months from the last dose of sonidegib.

Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 6 months after the last dose.

Female patients with active contraception or no menstrual cycle for >12 months

Exclusion criteria

Inoperable basal cell carcinoma tumours.

A concurrent cancer diagnosis requiring any systemic anti-cancer therapy.

Serious or unstable pre-existing medical conditions or other conditions or laboratory abnormalities that could interfere with the patient's safety, consent, or compliance.

History of malabsorption or other conditions that would interfere with the absorption of sonidegib.

Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial.

Prior treatment with hedgehog pathway inhibitors.

Concomitant medications that may result in increased or decreased bioavailability of sonidegib.

Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, rhabdomyolysis, amyotrophic lateral sclerosis and spinal muscular atrophy) due to an increased risk of muscle toxicity with sonidegib.

Male patients expecting to father children or donate sperm during the 12 weeks of sonidegib treatment and for a further 6 months from the end of treatment.

Pregnant or breastfeeding women

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2019-07-23

Primary completion: 2024-06-01

Study completion finish: 2024-06-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT03534947

Intervention or treatment

DRUG: Sonidegib

DRUG: Imiquimod

PROCEDURE: Surgery

OTHER: Best supportive care

Conditions

• Basal Cell Carcinoma
• Skin Cancer
• Basal Cell Carcinoma of Skin, Site Unspecified
• Invasive Carcinoma

Condition: Basal Cell Carcinoma, Skin Cancer and more
DRUG: Sonidegib and other drugs
North Sydney, New South Wales, Australia
Sponsor: Melanoma Institute Australia

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Melanoma Institute Australia

Research sites nearby

Select from list below to view details:

Melanoma Institute Australia
North Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Sonidegib followed by imiquimod Sonidegib 200mg taken orally once a day for 12 weeks. COMPLETE OR PARTIAL RESPONSE WITH SUPERFICAL REMNANT LESION For patients with a complete response or a partial response resulting in a superficial lesion, treatment with topical imiquimod for 5 days a week for 6 weeks will be prescribed.	DRUG: Sonidegib Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.
EXPERIMENTAL: Sonidegib followed by surgery Sonidegib 200mg taken orally once a day for 12 weeks. PARTIAL RESPONSE WITH REMNANT INVASIVE LESION For patients with a no change on BCC size / depth or patients with a partial response but a remaining invasive lesion, will have surgical excscion of the remaining lesion.	DRUG: Sonidegib Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.
OTHER: Sonidegib then best supportive care Sonidegib 200mg taken orally once a day for 12 weeks. PROGRESSIVE DISEASE Patients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions.	DRUG: Sonidegib Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Neoadjuvant treatment response determined by optical coherence tomography	The size and spread of abnormal skin structures associated with basal cell carcinoma detected by optical coherence tomography.	12 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Neoadjuvant treatment response determined by histopathology	The size and spread of basal cell carcinoma tumour in a biopsy taken from the known worse affected area of disease demonstrated by histopathologic analysis.	12 weeks
Histologic response to neoadjuvant treatment in basal cell carcinoma sub types	The amount and spread of basal cell carcinoma tumour cells and structures detected at histopathology analysis in nodular and in infiltrative sub types of BCC.	12 weeks
Response to neoadjuvant treatment in basal cell carcinoma sub types measured with optical coherence tomography.	The amount and spread of basal cell carcinoma tumour cells and structures detected at histopathology analysis in nodular and in infiltrative sub types of BCC.	12 weeks
Recurrence rate	The number of patients who have a recurrence of basal cell carcinoma at the original site of disease after having surgery or 6 weeks of topical treatment with imiquimod.	6 and 12 months after surgery or at the end of 6 weeks of treatment with imiquimiod.
Drug related adverse reactions	The proportion of patients experiencing any adverse drug reactions graded according to CTCAE version 4.	12 weeks
Discontinuation of sonidegib due to adverse reactions	The proportion of patients who discontinue sonideigb because of adverse drug reactions.	12 weeks
Quality of life based on SKINDEX-16	The scores obtained from the validated SKINDEX-16 quality of life questionnaire compared to baseline.	Weeks 12 and 18 and months 6 and 12.
Patient rated cosmetic outcome after neoadjuvant treatment followed by surgery	Scores from a 3 likert scale questions assessing the patient's agreement with statements about the appearance of their surgical scar for patients who need surgery after neoadjuvant treatment.	Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment followed by surgery	Scores from a 3 likert scale questions assessing the surgeon's agreement with statements about the appearance of their surgical scar for patients who need surgery after neoadjuvant treatment.	Week 12
Patient rated cosmetic outcome after neoadjuvant treatment	Scores from a 3 likert scale questions assessing the patient's agreement with statements about the appearance of the remmant BCC area for patients who did not need surgery after neoadjuvant treatment.	Week 12
Surgeon rated cosmetic outcome after neoadjuvant treatment	Scores from a 3 likert scale questions assessing the surgeons's agreement with statements about the appearance of the remmant BCC area for patients who did not need surgery after neoadjuvant treatment.	Week 12

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma