Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
rate of objective response after 6 months of treatment
Primary endpoint is the proportion of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment. The primary endpoint is based on central (radiological) review of tumor assessments as per modified RECIST (mRECIST) criteria for locally advanced basal cell carcinoma (laBCC)and RECIST 1.1 criteria for metastatic basal cell carcinoma (mBCC)
6 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLDE225A2201
NCT01327053
June 2011
August 2014
Name | Location |
---|---|
Texas Oncology Cancer Care & Research Center | Waco, Texas 76712 |
Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
Henry Ford Hospital Henry Ford | Detroit, Michigan 48202 |
Texas Oncology, P.A. Texas Onc - Amarillo | Dallas, Texas 75246 |
MD Anderson Cancer Center/University of Texas MD Anderson | Houston, Texas 77030-4009 |
Stanford University Medical Center Stanford Univ 2 | Stanford, California 94304 |
University of Colorado UC | Aurora, Colorado 80045 |
Washington Hospital Center Wash Hospital | Washington, District of Columbia 20010 |
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator | Chicago, Illinois 60611 |
Dana Farber Cancer Institute DFCI - MA | Boston, Massachusetts 02115 |
Washington University School Of Medicine-Siteman Cancer Ctr Siteman | St. Louis, Missouri 63110 |
Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2) | Las Vegas, Nevada 89109 |
Hackensack University Medical Center Hackensack (SC) | Hackensack, New Jersey 07601 |
Penn State University / Milton S. Hershey Medical Center Hershey Medical | Hershey, Pennsylvania 17033-085 |
University of Pittsburgh Medical Center UPMC | Pittsburgh, Pennsylvania |
Texas Oncology, P.A. Tex Onc 3 | Dallas, Texas 75246 |
Texoma Cancer Center Texoma Cancer Center | Wichita Falls, Texas 76310 |
University of Utah / Huntsman Cancer Institute Huntsman/Univ UT | Salt Lake City, Utah 84103 |
Baylor College of Medicine Baylor Texas Oncology | Dallas, Texas 75246 |
University of California at Los Angeles UCLA 3 | Los Angeles, California 90095 |
oH. Lee Moffitt Cancer Center/University of South Florida Cutaneous Onc Dept | Tampa, Florida 33612 |
New York University Medical Center SC-2 | New York, New York 10016 |