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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma

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Trial Information

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


Inclusion Criteria:



- Patients with locally advanced BCC and metastatic BCC

- Patients with adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Patients who have 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 are on concurrent therapy with other anti-neoplastic agents.

- Patients who have 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 are unwilling or unable to comply with the protocol.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

rate of objective response after 6 months of treatment

Outcome Description:

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)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLDE225A2201

NCT ID:

NCT01327053

Start Date:

June 2011

Completion Date:

August 2014

Related Keywords:

  • Basal Cell Carcinoma
  • locally advanced basal cell carcinoma,
  • metastatic basal cell carcinoma
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Texas Oncology Cancer Care & Research CenterWaco, Texas  76712
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
Henry Ford Hospital Henry FordDetroit, Michigan  48202
Texas Oncology, P.A. Texas Onc - AmarilloDallas, Texas  75246
MD Anderson Cancer Center/University of Texas MD AndersonHouston, Texas  77030-4009
Stanford University Medical Center Stanford Univ 2Stanford, California  94304
University of Colorado UCAurora, Colorado  80045
Washington Hospital Center Wash HospitalWashington, District of Columbia  20010
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinatorChicago, Illinois  60611
Dana Farber Cancer Institute DFCI - MABoston, Massachusetts  02115
Washington University School Of Medicine-Siteman Cancer Ctr SitemanSt. 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 MedicalHershey, Pennsylvania  17033-085
University of Pittsburgh Medical Center UPMCPittsburgh, Pennsylvania  
Texas Oncology, P.A. Tex Onc 3Dallas, Texas  75246
Texoma Cancer Center Texoma Cancer CenterWichita Falls, Texas  76310
University of Utah / Huntsman Cancer Institute Huntsman/Univ UTSalt Lake City, Utah  84103
Baylor College of Medicine Baylor Texas OncologyDallas, Texas  75246
University of California at Los Angeles UCLA 3Los Angeles, California  90095
oH. Lee Moffitt Cancer Center/University of South Florida Cutaneous Onc DeptTampa, Florida  33612
New York University Medical Center SC-2New York, New York  10016