Open-label Trial of SUBA™-Itraconazole (SUBA-Cap) in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)
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|ClinicalTrials.gov Identifier: NCT02354261|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma in Basal Cell Nevus Syndrome||Drug: SUBA-Itraconazole||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIb Open-label Trial of SUBA™-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)|
|Actual Study Start Date :||August 7, 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
Subjects will receive an oral dose of 300 mg SUBA-itraconazole daily.
Subjects will receive an oral dose of 300 mg SUBA-Itraconazole daily.
Other Name: SUBA-Cap
- Response rate of BCC lesions [ Time Frame: Up to 26 weeks ]
- Safety and tolerance; measured by number of subjects with adverse events [ Time Frame: Participants will be followed for the duration of study participation, an expected average of 26 weeks ]
- Number of new BCCs eligible for surgical resection [ Time Frame: Up to 26 weeks ]
- Duration of response in those subjects that have responded [ Time Frame: Up to 26 weeks ]
- Time to next therapy (systemic therapy or surgical intervention) [ Time Frame: Up to 26 weeks ]
- Change in the number of jaw cysts [ Time Frame: Up to 26 weeks ]
- Changes in the number of palmar/plantar pits [ Time Frame: Up to 26 weeks ]
- Gli1 expression in normal skin [ Time Frame: Up to 26 weeks ]
- Levels of itraconazole and hydroxy-itraconazole in the skin [ Time Frame: Up to 26 weeks ]
- Levels of itraconazole and hydroxy-itraconazole in the blood [ Time Frame: For Cycle 1 and Cycle 2, Up to week 8 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02354261
|United States, California|
|Dermatology Specialists, Inc|
|Oceanside, California, United States, 92056|
|United States, Florida|
|Ormond Beach, Florida, United States, 32174|
|United States, Michigan|
|Grekin Skin Institute|
|Warren, Michigan, United States, 48034|
|United States, New York|
|Stony Brook University|
|East Setauket, New York, United States, 11733|
|United States, Pennsylvania|
|Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||James Solomon, MD, PhD||Ameriderm Clinical Research|