A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
NCT ID: NCT01327053
Last Updated: 2019-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2011-06-29
2018-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LDE225 200 mg
The study was double blinded and enrolled at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225
LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
LDE225 800 mg
The study was double blinded and enrolled at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225
LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
Interventions
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LDE225
LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with adequate bone marrow, liver, and renal function
Exclusion Criteria
* Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
* Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
* Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage.
* Patients who were on concurrent therapy with other anti-neoplastic agents.
* Patients who had taken part in an experimental drug within 4 weeks of initiation of study medication.
* Pregnant or nursing (lactating) women
* Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
* Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
* Patients who were unwilling or unable to comply with the protocol.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
University of California at Los Angeles UCLA 3
Los Angeles, California, United States
Stanford University Medical Center Stanford Univ 2
Stanford, California, United States
University of Colorado School of Medicine UC
Aurora, Colorado, United States
Washington Hospital Center Wash Hospital
Washington D.C., District of Columbia, United States
H Lee Moffitt Cancer Center and Research Institute Cutaneous Onc Dept
Tampa, Florida, United States
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator
Chicago, Illinois, United States
Dana Farber Cancer Institute DFCI - MA
Boston, Massachusetts, United States
Henry Ford Hospital Henry Ford
Detroit, Michigan, United States
Washington University School Of Medicine-Siteman Cancer Ctr Siteman
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)
Las Vegas, Nevada, United States
Hackensack University Medical Center Hackensack (SC)
Hackensack, New Jersey, United States
New York University Medical Center SC-2
New York, New York, United States
Penn State University / Milton S. Hershey Medical Center Hershey Medical
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC
Pittsburgh, Pennsylvania, United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Dallas, Texas, United States
Texas Oncology Tex Onc 3
Dallas, Texas, United States
Texas Oncology Texas Onc - Amarillo
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center MD Anderson
Houston, Texas, United States
Texas Oncology Cancer Care & Research Center
Waco, Texas, United States
Texoma Cancer Center Texoma Cancer Center
Wichita Falls, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman/Univ UT
Salt Lake City, Utah, United States
Novartis Investigative Site
St Leonards, New South Wales, Australia
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Geelong, Victoria, Australia
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Brussels, , Belgium
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Wilrijk, , Belgium
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Waterloo, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Lyon, , France
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Marseille, , France
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Pierre-Bénite, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Gera, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Mainz, , Germany
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München, , Germany
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Münster, , Germany
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Stade, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Torino, TO, Italy
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Napoli, , Italy
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Barcelona, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Bern, , Switzerland
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Geneva, , Switzerland
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Zurich, , Switzerland
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High Heaton, Newcastle Upon Tyne, United Kingdom
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Yeovil, Somerset, United Kingdom
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Cardiff, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Gutzmer R, Robert C, Loquai C, Schadendorf D, Squittieri N, Arntz R, Martelli S, Dummer R. Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis. BMC Cancer. 2021 Nov 19;21(1):1244. doi: 10.1186/s12885-021-08968-1.
Lewis K, Dummer R, Farberg AS, Guminski A, Squittieri N, Migden M. Effects of Sonidegib Following Dose Reduction and Treatment Interruption in Patients with Advanced Basal Cell Carcinoma During 42-Month BOLT Trial. Dermatol Ther (Heidelb). 2021 Dec;11(6):2225-2234. doi: 10.1007/s13555-021-00619-4. Epub 2021 Oct 20.
Lear JT, Migden MR, Lewis KD, Chang ALS, Guminski A, Gutzmer R, Dirix L, Combemale P, Stratigos A, Plummer R, Castro H, Yi T, Mone M, Zhou J, Trefzer U, Kaatz M, Loquai C, Kudchadkar R, Sellami D, Dummer R. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):372-381. doi: 10.1111/jdv.14542. Epub 2017 Nov 6.
Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornelis F, Lear JT, Sellami D, Dummer R. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015 Jun;16(6):716-28. doi: 10.1016/S1470-2045(15)70100-2. Epub 2015 May 14.
Other Identifiers
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2010-022629-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDE225A2201
Identifier Type: -
Identifier Source: org_study_id
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