Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the G… (NCT02828111) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas
United States36 participantsStarted 2016-11-11
Plain-language summary
This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational center (metasite) in the United States will participate in this study. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. The participant is from 18 to 85 years of age, inclusive.
✓. The participant must provide electronic informed consent prior to any study procedures.
✓. If the participant is a woman of childbearing potential, she is willing to use two effective methods of birth control during the duration of the trial and for one month after the last application of the gel. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline; hormonal intra-uterine device (IUD) inserted at least 1 month prior to Baseline. This proscription is based on the key role of the hedgehog (HH) pathway in embryogenesis, the known preclinical teratogenic effects of systemic cyclopamine, a naturally occurring inhibitor of smoothened (SMO), and the unknown level of systemic exposure following topical application of patidegib in humans.
✓. If the participant is a male with a female sexual partner who is of childbearing potential, the couple is willing to use two effective methods of birth control during the duration of the trial and for one month after the last application of the gel. Authorized birth control methods are outlined in Inclusion Criterion #3. Any woman of childbearing potential applying the gel to themselves, or assisting a subject, must comply with the same birth control measures.
✓
What they're measuring
1
Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug
Timeframe: Baseline through Week 12
2
Molecular Efficacy: Percent Change From Baseline in the Hedgehog (HH) Signaling Pathway Target Gene Glioma-associated Oncogene Homolog 1 (GLI1) Messenger Ribonucleic Acid (mRNA) Levels at Week 12
. One or two previously untreated basal cell carcinomas (BCCs) with the clinical features of a nodular BCC confirmed by a biopsy done at or prior to screening confirming nodular BCC. These tumors must be suitable for surgical excision. The BCCs prior to biopsy must be no less than 5 millimeters (mm) or greater than 15 mm in greatest diameter on the face and no less than 9 mm or more than 20 mm in greatest diameter at sites other than the face. Tumors on the nose, periorbital skin, or on or below the knee are excluded.
✓. The participant is willing to abstain from application of non-study topical prescription and over the counter medications within 5 centimeters (cm) of a treatment-targeted BCC for the duration of the study except as prescribed by the Investigator. Moisturizers and emollients are allowable. Subjects will be encouraged to use sunscreen with a sunscreen protection factor (SPF 15 or higher) at least once daily on all exposed skin sites.
✓. Female participant must have negative serum pregnancy test at Screening.
✓. The participant is willing to contact the study center after each primary skin care physician (PSCP) visit to provide the study center details of the visit and any treatment of skin tumors.
Exclusion criteria
✕. Participants with basal cell nevus syndrome (BCNS, Gorlin syndrome, nevoid basal cell carcinoma syndrome; Online Mendelian Inheritance in Man \[OMIM\] #109400).
✕. The participant has used topical products within 5 cm of a treatment- targeted BCC or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the use of:
✕. Topical glucocorticoids 30 days prior to screening
✕. Retinoids (such as etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically, or \> 5% of an alphahydroxy acid (such as glycolic acid, lactic acid), photodynamic therapy (PDT), or 5-fluorouracil or imiquimod (except as topical treatment to discrete BCCs) systemically or topically to the skin during the six months prior to entry.
✕. Systemic chemotherapy within one year prior to screening. (Note: field therapy with topically applied treatments can be done as long as they are not applied within 5 cm of a treatment-targeted tumor).
✕. Known inhibitors of the HH signaling pathway (such as vismodegib, patidegib, sonidegib, and itraconazole) topically or systemically within 6 months of entry into the study.
✕. The participant has a history of hypersensitivity to any of the ingredients in the study medication formulation.
✕. The participant is unable or unwilling to make a good faith effort to be present for all follow-up visits and tests.