Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01529450
Other study ID # SKIN0009
Secondary ID SU-09022011-8371
Status Terminated
Phase N/A
First received October 11, 2011
Last updated February 5, 2015
Start date February 2012
Est. completion date August 2013

Study information

Verified date February 2015
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.

Primary Objectives:

• To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor.

Secondary Objectives:

- To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment

- To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage

- To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225


Description:

This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.

Primary Objectives:

• To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor.

Secondary Objectives:

- To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment

- To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage

- To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age 18 years or older.

2. Histologically documented diagnosis of basal cell carcinoma deemed to be locally advanced or metastatic who have previously received a non-LDE225 Smo inhibitor.

3. WHO performance status <= 2

4. At least one measurable site of disease (as defined by Response Evaluation Criteria in Solid Tumors), or other disease specific response assessment criteria, as appropriate. State age restriction and/or gender/race-ethnic restrictions.

5. Patients with adequate bone marrow, liver and renal function, as specified below:

- Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L

- Hemoglobin (Hgb) >= 9 g/dL

- Platelets >= 80 x 10^9/L

- Serum total bilirubin <= 1.5 x ULN(upper limit of normal)

- AST and ALT <= 2.5 x ULN or <= 5 x ULN if liver metastases are present

- Plasma creatine phosphokinase (CK) < 1.5 x ULN

- Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 50ml/min

6. Written informed consent obtained prior to any screening procedures

Exclusion Criteria:

1. Patients who have had major surgery within 4 weeks of initiation of study medication.

2. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.

State restrictions regarding use of other Investigational Agents.

3. Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.

State exclusion requirements due to co-morbid disease or incurrent illness, as needed.

4. Patients who have previously been treated with systemic LDE225.

5. Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil, and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment. If it is essential that the patient stays on a statin to control hyperlipidemia, only pravastatin may be used with extra caution.

b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment.

6. Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225.

7. Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with LDE225.

8. Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.

9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).

10 Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include:

- Diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

- Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.

11 Patients unwilling or unable to comply with the protocol.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
LDE225
800-mg (4 200-mg capsules/day) capsule

Locations

Country Name City State
United States Stanford University Cancer Institute Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Anne Chang Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor End of Treatment or 12 months whichever comes first No
Secondary Biomarker levels of oral LDE225 on tumor tissue biomarkers of BCC activation (Gli 1, 2, Patched 1,2 and Ki67) in individuals which are non-naïve to Smo inhibitors other than LDE225 End of treatment or 12 months whichever comes first No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04552990 - Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma Phase 2
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT05608902 - Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Completed NCT05077033 - Intratumoral phIL12 GET Phase 1
Active, not recruiting NCT04928222 - Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) Phase 1/Phase 2
Recruiting NCT04929535 - Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment Phase 2
Completed NCT02662244 - Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma N/A
Completed NCT00959647 - A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study Phase 2
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00473343 - Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma Phase 3
Active, not recruiting NCT06024629 - cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Not yet recruiting NCT05324202 - New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT01260987 - Fractional CO2 Laser Assisted Photodynamic Therapy Phase 2/Phase 3
Completed NCT01201915 - A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma Phase 2
Completed NCT01208831 - An East Asian Study of LDE225 Phase 1
Completed NCT01014819 - A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions N/A
Completed NCT00472043 - PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma Phase 3