Basal Cell CarcinomasPhase 2BCCNCT02828111
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
A Phase 2 study testing Patidegib in people with Basal Cell Carcinomas, run by PellePharm, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Basal Cell Carcinomas
- What is being tested?
- Patidegib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to 9 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
- The participant is willing to forego alternative treatment of the treatment-targeted baseline BCC for the duration of the trial.
Who cannot join
- 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.
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- 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.
- The participant is a woman who is currently nursing.
- The participant has any systemic disease that in the Investigator's opinion would interfere with the subject's ability to participate.
- The participant has a clinically significant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis, that in the investigator's opinion would interfere with the participant's ability to participate.
- The participant has 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 participant's participation in the study. This includes history of other skin conditions or diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of this investigational drug or that might affect interpretation of the results of the study or render the participant at high risk from treatment complications.
- The participant has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of breast, or chronic lymphocytic lymphoma (CLL) (Stage 0).
- The participant is currently participating in an experimental drug study (within 4 weeks of Baseline visit) or plans to participate in an experimental drug study while enrolled in this study.
- The participant is on a concomitant medication that is a strong CYP3A4 inhibitor. These include, but are not limited to: larithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.
Trial locations and contacts
1 site in 1 country.
United States1 site
12121 Bluff Creek Drive Suite 100
Los Angeles, California, 90094
About this study
Official title: Double-Blind, Dose Escalating, Randomized, Vehicle-Controlled Proof of Concept 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
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.
Read the detailed description
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. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. As soon as one cohort has been completely enrolled, the next cohort will be enrolled. Each subject will treat no more than two previously untreated biopsy confirmed treatment-targeted nodular BCCs. If the subject has additional non-treatment targeted BCCs they can be treated surgically prior to or during the trial. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel. The sequential cohorts will be:
- Cohort 1: patidegib gel 2% or vehicle, once daily
- Cohort 2: patidegib gel 4% or vehicle, once daily
- Cohort 3: patidegib gel 2% or vehicle, twice daily
- Cohort 4: patidegib gel 4% or vehicle, twice daily
The study drug will be applied topically to the treatment-targeted BCCs and a rim of adjacent skin for 12 weeks. Information on reported and observed adverse events (AEs) will be obtained at each visit. An abbreviated physical examination (PE) will be performed at Baseline and Week 12. The treatment-targeted BCCs will be identified by the Investigator at the Baseline visit and will be circled in ink at Baseline, Weeks 6 and 12 and photographed, and measured at all study visits (Baseline, Weeks 2, 6, 8, 10, and 12). Blood samples for complete blood count and serum chemistry and urine for urinalysis will be collected from subjects at Screening, Week 6, and Week 12. Subjects who terminate study participation early will be asked to complete all Week 12 assessments, as appropriate, prior to commencement of any alternative therapy for BCCs (if possible). Subjects who discontinue from the study during the treatment period will not be replaced.
- Conditions
- Basal Cell Carcinomas
- Being tested
- Patidegib, Vehicle gel
- Keywords
- Gorlin Syndrome, Basal Cell Nevus Syndrome BCNS, nevoid basal cell carcinoma syndrome, Basal cell carcinoma, Hedgehog inhibitor, Surgically Eligible Basal Cell Carcinomas, High Frequency Basal Cell Carcinomas
- Medical subject headings
- Carcinoma, Basal Cell, Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatidegibDrug
Also called Study drug
Vehicle gelDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Patidegib gel 2% - Cohort 1 | Experimental | Patidegib gel 2%, applied topically, once daily for 12 weeks (Cohort 1) Receives: Drug: Patidegib |
| Patidegib gel 4% - Cohort 2 | Experimental | Patidegib gel 4%, applied topically, once daily for 12 weeks (Cohort 2) Receives: Drug: Patidegib |
| Vehicle gel - Cohort 1 | Placebo comparator | Vehicle gel, applied topically, once daily for 12 weeks (Cohort 1) Receives: Drug: Vehicle gel |
| Patidegib gel 2% - Cohort 3 | Experimental | Patidegib gel 2%, applied topically, twice daily for 12 weeks (Cohort 3) Receives: Drug: Patidegib |
| Patidegib gel 4% - Cohort 4 | Experimental | Patidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4) Receives: Drug: Patidegib |
| Vehicle gel - Cohort 2 | Placebo comparator | Vehicle gel, applied topically, once daily for 12 weeks (Cohort 2) Receives: Drug: Vehicle gel |
| Vehicle gel - Cohort 3 | Placebo comparator | Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 3) Receives: Drug: Vehicle gel |
| Vehicle gel - Cohort 4 | Placebo comparator | Vehicle gel, applied topically, twice daily for 12 weeks (Cohort 4) Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug
All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs (including both serious and non-serious) considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.
Measured: Baseline through Week 12
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
GLI1 change is a biomarker of the HH signaling pathway. A change in GLI1 mRNA levels reflect a change in the HH pathway. Surgically eligible basal cell carcinomas (SEBs) were defined as clinically diagnosed basal cell carcinoma (BCC) 5 to 20 millimeters (mm) in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. A single baseline BCC designated as a treatment-targeted tumor at Baseline was biopsied first at Baseline and again following 12 weeks of treatment. This was used to assess percent change in GLI1 mRNA levels as follows: (Baseline - Week 12) / Baseline * 100, with positive numbers to represent increases and negative numbers to represent decreases. Any missing values were not imputed; all available data is summarized.
Measured: Baseline, Week 12
Secondary outcomes (2)
Clinical Efficacy: Percent Change From Baseline in Tumor Size of Treatment-targeted SEBs at Week 12
SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percent change in greatest diameters of treatment-targeted surgically eligible basal cell carcinomas (SEBs) from Baseline to Week 12 was calculated as follows: (sum [Baseline] - sum [Week 12] / sum [Baseline] * 100), where sum = the greatest diameters of treatment-targeted SEBs and positive numbers to represent increases and negative numbers to represent decreases. Missing values were imputed using Last-Observation Carried Forward (LOCF).
Measured: Baseline, Week 12
Clinical Efficacy: Percentage of SEBs Showing Complete or Partial Response at Week 12 as Determined by Blinded Photographic Review
SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of tumors showing a complete or partial response at Week 12 was calculated as follows: (Number of baseline treatment-targeted SEBs showing complete or partial response at Week 12) / (Number of Baseline treatment-targeted SEBs) * 100. Missing values were not imputed.Complete Response is determined when there is no longer any visible evidence of a lesion consistent with BCC at the site, and Partial Response is determined when although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start11 Nov 2016
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Cell CarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- PellePharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ervin Epstein, MD, Study director, PellePharm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828111
- Sponsor's protocol ID
- Pelle-926-202
- Acronym
- BCC
- Status last verified
- Jan 2019
- First submitted
- 1 Jul 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Dose Escalating, Randomized, Vehicle-Controlled Proof of Concept 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
- ClinicalTrials.gov ID
- NCT02828111
- Acronym / sponsor ID
- BCC / Pelle-926-202
- Conditions
- Basal Cell Carcinomas
- Keywords
- Gorlin Syndrome, Basal Cell Nevus Syndrome BCNS, nevoid basal cell carcinoma syndrome, Basal cell carcinoma, Hedgehog inhibitor, Surgically Eligible Basal Cell Carcinomas, High Frequency Basal Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PellePharm, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 4 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. As soon as one cohort has been completely enrolled, the next cohort will be enrolled. Each subject will treat no more than two previously untreated biopsy confirmed treatment-targeted nodular BCCs. If the subject has additional non-treatment targeted BCCs they can be treated surgically prior to or during the trial. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel. The sequential cohorts will be:
- Cohort 1: patidegib gel 2% or vehicle, once daily
- Cohort 2: patidegib gel 4% or vehicle, once daily
- Cohort 3: patidegib gel 2% or vehicle, twice daily
- Cohort 4: patidegib gel 4% or vehicle, twice daily
The study drug will be applied topically to the treatment-targeted BCCs and a rim of adjacent skin for 12 weeks. Information on reported and observed adverse events (AEs) will be obtained at each visit. An abbreviated physical examination (PE) will be performed at Baseline and Week 12. The treatment-targeted BCCs will be identified by the Investigator at the Baseline visit and will be circled in ink at Baseline, Weeks 6 and 12 and photographed, and measured at all study visits (Baseline, Weeks 2, 6, 8, 10, and 12). Blood samples for complete blood count and serum chemistry and urine for urinalysis will be collected from subjects at Screening, Week 6, and Week 12. Subjects who terminate study participation early will be asked to complete all Week 12 assessments, as appropriate, prior to commencement of any alternative therapy for BCCs (if possible). Subjects who discontinue from the study during the treatment period will not be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patidegib gel 2% - Cohort 1 | Experimental | Drug: PatidegibPatidegib gel 2%, applied topically, once daily for 12 weeks (Cohort 1) |
| Patidegib gel 4% - Cohort 2 | Experimental | Drug: PatidegibPatidegib gel 4%, applied topically, once daily for 12 weeks (Cohort 2) |
| Vehicle gel - Cohort 1 | Placebo comparator | Drug: Vehicle gelVehicle gel, applied topically, once daily for 12 weeks (Cohort 1) |
| Patidegib gel 2% - Cohort 3 | Experimental | Drug: PatidegibPatidegib gel 2%, applied topically, twice daily for 12 weeks (Cohort 3) |
| Patidegib gel 4% - Cohort 4 | Experimental | Drug: PatidegibPatidegib gel 4%, applied topically, twice daily for 12 weeks (Cohort 4) |
| Vehicle gel - Cohort 2 | Placebo comparator | Drug: Vehicle gelVehicle gel, applied topically, once daily for 12 weeks (Cohort 2) |
| Vehicle gel - Cohort 3 | Placebo comparator | Drug: Vehicle gelVehicle gel, applied topically, twice daily for 12 weeks (Cohort 3) |
| Vehicle gel - Cohort 4 | Placebo comparator | Drug: Vehicle gelVehicle gel, applied topically, twice daily for 12 weeks (Cohort 4) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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:
- 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.
- The participant is a woman who is currently nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatidegibAlso: Study drug | Drug | Patidegib gel 2% - Cohort 1, Patidegib gel 2% - Cohort 3, Patidegib gel 4% - Cohort 2, Patidegib gel 4% - Cohort 4 |
| Vehicle gelAlso: Placebo | Drug | Vehicle gel - Cohort 1, Vehicle gel - Cohort 2, Vehicle gel - Cohort 3, Vehicle gel - Cohort 4 |
Primary outcome
Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug
Time frame: Baseline through Week 12
All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs (including both serious and non-serious) considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.
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
Time frame: Baseline, Week 12
GLI1 change is a biomarker of the HH signaling pathway. A change in GLI1 mRNA levels reflect a change in the HH pathway. Surgically eligible basal cell carcinomas (SEBs) were defined as clinically diagnosed basal cell carcinoma (BCC) 5 to 20 millimeters (mm) in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. A single baseline BCC designated as a treatment-targeted tumor at Baseline was biopsied first at Baseline and again following 12 weeks of treatment. This was used to assess percent change in GLI1 mRNA levels as follows: (Baseline - Week 12) / Baseline * 100, with positive numbers to represent increases and negative numbers to represent decreases. Any missing values were not imputed; all available data is summarized.
2 secondary outcomes
Clinical Efficacy: Percent Change From Baseline in Tumor Size of Treatment-targeted SEBs at Week 12
Time frame: Baseline, Week 12
Clinical Efficacy: Percentage of SEBs Showing Complete or Partial Response at Week 12 as Determined by Blinded Photographic Review
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ervin Epstein, MD study director
PellePharm, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patidegib in people with Basal Cell Carcinomas, run by PellePharm, Inc. at 1 site 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 9 inclusion and 15 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug (time frame: Baseline through Week 12). 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?
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 8 Jan 2019.