A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Completed · Phase 2 · Has a placebo group

Conditions studied: Basal Cell Carcinoma

In brief

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

Key facts

Study ID

NCT01327053

Run by

Novartis Pharmaceuticals

People needed

230

Starts

2011-06-29

Expected to finish

2018-06-29

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with locally advanced BCC and metastatic BCC
• Patients with adequate bone marrow, liver, and renal function

You may not qualify if…

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

Where it is running

• 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
• Novartis Investigative Site — Geelong, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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