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Basal Cell Carcinoma in Basal Cell Nevus SyndromePhase 2NCT02354261

Open-label Trial of SUBA™-Itraconazole (SUBA-Cap) in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)

A Phase 2 study testing SUBA-Itraconazole in people with Basal Cell Carcinoma in Basal Cell Nevus Syndrome, run by HedgePath Pharmaceuticals, Inc. at 5 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SUBA-Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
5 sitesUnited States
Study dates
7 Aug 2015to Mar 2019
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

  • ECOG performance status of 0 or 1
  • Diagnosis of Basal Cell Carcinoma Nevus Syndrome (BCCNS)
  • Histologic confirmation of BCC from at least one lesion
  • History of surgical removal of at least ten (10) prior BCCs
  • Measurable disease as defined, namely at least ten (10) measurable lesions such that the sum of the longest diameters of the measurable lesions is at least 40 mm.
  • Has failed, refused, or is not eligible for standard of care therapy for BCC
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  • Willingness to abstain from the use of non-study treatments for BCC, including but not limited to topical medications, PDT, and/or irradiation therapy.
  • At least four weeks from prior major surgery
  • Women who are pre-menopausal or not surgically sterile must be willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug
  • Sexually active men must be willing to use an acceptable contraceptive method for the duration of time on study and for 30 days following the last dose of study drug
  • Clinical laboratory values within the following ranges:
  • Negative serum pregnancy test
  • Adequate hematologic function (ANC ≥1.5 x 10^9/L; platelet count ≥75x10^9/L; hemoglobin ≥9g/dL (in the absence of red blood cell transfusions in the prior 14 days)
  • Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) <1.5 times the upper limit of normal range, unless currently receiving anticoagulants
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥60 mL/min
  • Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert syndrome in which case, ≤ 3x the upper limit of normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ the upper limit of normal
  • Willingness to undergo biopsies (BCC lesions and normal skin)
  • Willingness to provide prior and study-related BCC biopsies for central review
  • Willingness to participate in collection of pharmacokinetic samples
  • Willingness to not donate blood, semen, or eggs for the duration of the study and for 3 months following discontinuation of SUBA-Cap
  • Willingness to delay removal of otherwise surgically eligible BCC's

Who cannot join

  • Presence of metastatic BCC
  • Subjects who would be disserved significantly by a delay in conventional therapy, such as surgical intervention of their BCC
  • Prior use of a hedgehog inhibitor (e.g., sonidegib, vismodegib) or Itraconazole within the past 6 months
  • History of progressive disease on a hedgehog inhibitor (e.g., sonidegib, vismodegib) or other Hh pathway inhibitors for the treatment of BCC
  • Pregnant and/or nursing women
  • Use of any medications metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) known to lead to potentially serious and/or life threatening adverse events when used in conjunction with itraconazole
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  • Any illness that is likely to reduce absorption of oral medications
  • Corrected QT (Fridericia) interval of >450 msec for females and >430 msec for males
  • Use of any medications known to result in a prolongation of the QT interval
  • History of congestive heart failure or other cardiac abnormality that would contraindicate the use of itraconazole
  • Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study
  • Any indication of compromised liver function that would otherwise contraindicate use of itraconazole
  • Any concurrent malignancy, except for squamous cell carcinoma of the skin and cervical carcinoma in situ, that is likely to require treatment within the next two years or would interfere with study requirements
  • Psychiatric illness and/or social situations (e.g., excessive alcohol use or use of illicit drugs) that would interfere with study compliance
  • Known HIV infection, active hepatitis B or active hepatitis C infection (testing not required unless indicated by history)
  • Known allergy to itraconazole or any of its excipients

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Stony Brook University

    East Setauket, New York, 11733

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Dermatology Specialists, Inc

    Oceanside, California, 92056

  • Ameriderm Research

    Ormond Beach, Florida, 32174

  • Grekin Skin Institute

    Warren, Michigan, 48034

Other trials in United States

About this study

Official title: Phase IIb Open-label Trial of SUBA™-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)

The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome.

Read the detailed description

Single arm, phase IIb, multi-center, open-label study evaluating the use of oral SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome and non-metastatic Basal Cell Carcinoma.

Following informed consent, subjects will undergo a skin biopsy for Gli1 analysis and an assessment of extent of disease using both tumor measurements (using modified Response Evaluation Criteria in Solid Tumors criteria) and color photographs of the skin.

Subjects will receive daily oral SUBA-Cap, at a starting dose of 150 mg twice daily (BID). Reassessments of disease will be conducted at weeks 4, 8, 16, and then every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation. Subjects may continue to receive SUBA-Cap until disease progression (defined as the appearance of one or more new lesions or ulceration of a target lesion) that requires a change in therapy (surgical intervention or use of other systemic therapy) or the appearance of unacceptable side effects. Pharmacokinetic assessments (serial trough levels) will be performed at defined intervals and, when possible, prior to and following any dose adjustment. Skin biopsies will be taken for Gli1 expression at defined intervals.

Being tested
SUBA-Itraconazole
Keywords
Basal Cell Carcinoma Nevus Syndrome, BCCNS, BCC, itraconazole, basal cell carcinoma, locally advanced basal cell carcinoma
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.

  • SUBA-ItraconazoleDrug

    Also called SUBA-Cap

    Subjects will receive an oral dose of 300 mg SUBA-Itraconazole daily.

Study groups in NCT02354261
Study groupRoleWhat they receive
SUBA-ItraconazoleExperimentalSubjects will receive an oral dose of 300 mg SUBA-itraconazole daily.
Receives: Drug: SUBA-Itraconazole

What is being measured

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

  1. Response rate of BCC lesions

    Measured: Up to 26 weeks

Secondary outcomes (9)

  1. Safety and tolerance; measured by number of subjects with adverse events

    Measured: Participants will be followed for the duration of study participation, an expected average of 26 weeks

  2. Number of new BCCs eligible for surgical resection

    Measured: Up to 26 weeks

  3. Duration of response in those subjects that have responded

    Measured: Up to 26 weeks

  4. Time to next therapy (systemic therapy or surgical intervention)

    Measured: Up to 26 weeks

  5. Change in the number of jaw cysts

    Measured: Up to 26 weeks

  6. Changes in the number of palmar/plantar pits

    Measured: Up to 26 weeks

  7. Gli1 expression in normal skin

    Measured: Up to 26 weeks

  8. Levels of itraconazole and hydroxy-itraconazole in the skin

    Measured: Up to 26 weeks

  9. Levels of itraconazole and hydroxy-itraconazole in the blood

    Measured: For Cycle 1 and Cycle 2, Up to week 8

Timeline

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

  1. First posted3 Feb 2015 (estimated)
  2. Study start7 Aug 2015
  3. Primary completionMar 2019
  4. Study completionMar 2019

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354261
Sponsor's protocol ID
HP2001
Other IDs
SCORING
Status last verified
Aug 2020
First submitted
21 Jan 2015
Last updated
5 Aug 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUBA-Itraconazole in people with Basal Cell Carcinoma in Basal Cell Nevus Syndrome, run by HedgePath Pharmaceuticals, Inc. at 5 sites in United States.

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 22 inclusion and 16 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

Response rate of BCC lesions (time frame: Up to 26 weeks). 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 NCT02354261.

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 5 Aug 2020.

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