Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Dirk Schadendorf, Professor

The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.

This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).

The primary effectiveness objective for this study is as follows:

• To evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.

The secondary effectiveness objectives for this study are as follows:

* Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
* Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
* Recurrence rate: rate of patients who responded (CR or PR) and later progressed
* Time to progression: time from first treatment to progression
* Time to death: time from first treatment to death
* Time to response: time from first treatment to response

The explorative objectives of this study are to evaluate the following endpoints:

* Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)
* Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)
* Utilization

  * Previous treatment for the BCC lesion, which led to therapy with Vismodegib
  * BCC therapy after Vismodegib therapy (if applicable)
  * Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)
  * Assessment of duration and time point of treatment interruptions of Vismodegib
  * Reason for treatment discontinuation

Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

- type of tumor response as determined by the treating physician by clinical assessment and/or histological assessment and/or imaging assessment

- treatment decision for therapy with Vismodegib by tumor board OR by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist

- previous treatment for the BCC lesion, which led to therapy with Vismodegib

- time to treatment interruptions of Vismodegib

- reason for treatment discontinuation of Vismodegib

The primary effectiveness measure for this study is as follows:

• To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.

number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment

time from first dose Vismodegib to complete response or partial response up to 3 years

number of complete response, partial response, stable disease

number of patients who responded (partial or complete) and later progressed

time from first dose Vismodegib to progression up to 3 years

time from first dose Vismodegib to death of any cause

OnkoDataMed GmbH

University Hospital, Essen

Prof. Dr. med.

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Anti-Bacterial Agents

Bupivacaine

Antibiotics, Antitubercular

10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications.

The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn.

Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).

Intralesional cryotherapy

Yaron har-Shai, M.D

Tamir Gil, M.D

Yaron Har-Shai, M.D

A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment

BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.

surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.

Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study

Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate

Carmel Medical Center

Head of plastic department

Symptoms and General Pathology

Neoplasm Metastasis

Syndrome

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

BMS-833923 (XL139)

Bristol-Myers Squibb

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule

A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

A Phase 1 Multiple Ascending Dose Study of BMS-833923 in Subjects With Advanced or Metastatic Solid Tumors

Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923

glioma-associated oncogene family of transcription factors (GLI)

Tumor assessments by computed tomography (CT)

The results of vital sign measurements, electrocardiogram (ECGs), pulmonary function tests, multigated radionuclide angiography (MUGA) or echocardiograms, physical examinations, and clinical laboratory tests

Exelixis

Skin and Connective Tissue Diseases

Skin Neoplasms

Itraconazole

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, stratified by prior vismodegib history

Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months

Patients otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment

* Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
* Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months

Jean Y Tang, MD

Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

Thus, it may reduce BCC growth in humans.

Participants with at least one BCC tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole.

* Cohort A - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by:

  * Cohort A1 - Participants are vismodegib-naive.
  * Cohort A2 - Participants had received prior vismodegib treatment.
* Cohort B - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). The objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment.
* Control Group - Tumors from untreated participants.

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas

Percent change in Ki67 tumor proliferation biomarker was assessed at baseline and after 1 month of treatment, for Cohort A1 (vismodegib-naïve participants receiving 400 mg as 200 mg twice daily) vs control patients. The outcome is expressed as the % change from baseline of cells with a positive signal after staining for Ki67.

* Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients, \& is reported as the mean of the changes observed for those lesions for which both baseline and treated valued are available.
* Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients, and is reported as the change in mean of the group of baseline basal cell carcinoma (BCC) lesion measurements and the group of treated BCC lesion measurements.

Tumor biomarker GLI1 (glioma-associated oncogene 1), part of the Hedgehog (HH) pathway, was assessed in vismodegib-naïve participants at baseline and after 1 month of treatment by quantitative polymerase chain reaction (qPCR). The relative expression of the biomarker was measured as the fold increase of GLI1 expression compared to that of housekeeping gene hypoxanthine-guanine phosphoribosyltransferase (HPRT), and the outcome was assessed as the percent change from the mean of the pre-treatment measurements to the mean of the post-treatment measurements. A negative mean indicates an overall reduction in GLI1 expression.

Tumor size was assessed by caliper measurement of the longest perpendicular diameters before and after itraconazole treatment, and determination of tumor area by multiplication of the measurements for each tumor. The outcome is expressed as the mean percent change in tumor area from baseline, with standard deviation. A negative value indicates a reduction in size.

The following criteria for basal cell carcinoma (BCC) tumor response were used.

* Complete response (CR) means no visible evidence of any lesion consistent with BCC
* Partial response (PR) means less than CR, but there was a visible decrease in BCC tumor size
* No response (NR) / Stable Disease (SD) means no visible decrease in BCC tumor size
* Progressive disease (PD) means an increase in size or number of BCC tumor lesions

Treatment assessment was conducted on the basis of lesion photographs by a dermatologist investigator who was blinded to the assigned treatment.

Stanford University

Associate Professor of Dermatology

All patients treated with itraconazole were monitored for adverse events ≥ Grade 2. Only adverse events (AEs) grade 2 or greater were collected and reported.

Oral itraconazole 400 mg as 200 mg twice daily, for 1 month.

Cohort A1 - Itraconazole 400 mg +/- Prior Vismodegib

Cohort A2 - Itraconazole 400 mg (Prior Vismodegib)

Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve.

Cohort B - Itraconazole 200 mg (Vismodegib-naïve)

Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants without prior vismodegib treatment (vismodegib-naïve) and more than 1 lesion at baseline.

Cohort A1 - Itraconazole 400 mg (Vismodegib-naïve)

Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, for participants with prior vismodegib treatment, and more than 1 lesion at baseline.

Participants otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment

Untreated Control

Total

Age, Continuous

Sex: Female, Male

United States

Chile

Region of Enrollment

1 Tumor Lesion at Baseline

> 1 Tumor Lesion at Baseline

Number of Tumor Lesions at Baseline

Patients with one or more BCC tumors measuring 4 mm or greater in diameter were enrolled.

Jean Tang MD PhD, Associate Professor of Dermatology

Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).

Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.

% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment.

Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.

% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment.

Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.

% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month.

Unpaired Analysis

Paired Analysis

Participants otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment.

Ki67 tumor proliferation biomarker assessment was not performed for Cohorts A2 (itraconazole 400 mg \& prior vismodegib) and B (itraconazole 100 mg twice daily).

Ki67 Tumor Proliferation Biomarker

Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.

% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment.

Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve, and had more than 1 lesion at baseline.

Participants otherwise eligible but unwilling to take itraconazole were enrolled onto this study control arm, and received no treatment.

Analysis conducted for Cohorts A1 - Itraconazole 400 mg (Vismodegib-naive) and A2 - Itraconazole 400 mg (Prior Vismodegib) only. GLI1 tumor biomarker assessment was not performed for the Cohort B (100 mg twice daily); or Control Group.

Change of GLI1 Tumor Biomarker

Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.

Average tumor size reductions were compared between Cohort A1 and Cohort B.

Change in tumor area was assessed for only for Cohort A1 or B participants who had \> 1 basal cell carcinoma (BCC) tumor (42 and 14 lesions respectively). No Cohort A2 participants had \> 1 BCC tumor. No data were collected from untreated patients.

Tumor Size

Cohort A1 - Itraconazole 400 mg, (Vismodegib-naïve)

Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve, and had more than 1 lesion at baseline..

Tumor Response

Cohort B - Itraconazole 200 mg

Overall Study

Dermatologic Agents

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.

Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

BF-200 ALA

methyl-aminolevulinate

Rolf M. Szeimies, Prof. Dr.

Colin Morton, Dr.

The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart.

If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycle starting on the same day.

Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)

Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT

Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)).

Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.

Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint.

Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint.

Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris).

Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint.

Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:

* Skin surface
* Hyperpigmentation
* Hypopigmentation
* Mottled or irregular pigmentation
* Degree of scarring
* Atrophy

Cosmetic outcome categories are:

* Very good: 12 weeks sum score improved by at least 2 points compared to baseline
* Good: 12 weeks sum score improved by 1 point compared to baseline
* Satisfactory: 12 weeks sum score identical to the one at baseline
* Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline
* Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline

Accovion GmbH

Biofrontera Bioscience GmbH

Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Methyl-aminolevulinate

Age, Categorical

Ethnicity (NIH/OMB)

Clinical Trial Department

Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.

Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT

Lesion Complete Response Assessed 12 Weeks After the Last PDT

Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline

Patient Complete Response 12 Weeks After PDT-2

Very good

Good

Satisfactory

Unsatisfactory

Impaired

Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)

Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)

Per protocol analysis set in the follow-up (PPS-FUP): all patients of the full analysis set in the follow-up (FAS-UP) without any major protocol deviations

Patient Recurrence Rate (Overall, Cumulative)

Overall

sBCC

nBCC

Per protocol analysis in follow-up (PPS-FUP): All lesions in patients in the full analysis set in follow-up (FAS-FUP) without any major protocol deviations

Lesion Recurrence Rate (Cumulative)

Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions	NCT02781389	Basal Cell Carc...		18 Years -	University Hospital, Essen
Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study	NCT01633515	Basal Cell Carc...	Intralesional c...	60 Years -	Carmel Medical Center
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions	NCT02781389	Basal Cell Carc...		18 Years -	University Hospital, Essen
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer	NCT00670189	Hedgehog Pathwa... Smoothened Basal Cell Carc... Basal Cell Nevo...	BMS-833923 (XL1...	18 Years -	Bristol-Myers Squibb
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas	NCT01108094	Basal Cell Carc... Skin Cancer	Itraconazole	18 Years -	Stanford University
Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study	NCT01633515	Basal Cell Carc...	Intralesional c...	60 Years -	Carmel Medical Center
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer	NCT00670189	Hedgehog Pathwa... Smoothened Basal Cell Carc... Basal Cell Nevo...	BMS-833923 (XL1...	18 Years -	Bristol-Myers Squibb
Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy	NCT02144077	Basal Cell Carc...	BF-200 ALA methyl-aminolev...	18 Years -	Biofrontera Bioscience GmbH

Spots Global Cancer Trial Database for basal cell carcinoma (bcc)