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Clinical Trials (PDQ®)

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and underPharmaceutical / IndustryCAMN107A2203
NCT01844765

Trial Description

Summary

To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).

Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
  • Karnofsky or Lansky ≥ 50
  • Adequate renal, hepatic and pancreatic function
  • Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
  • Written informed consent

Exclusion Criteria:

  • Treatment with strong CYP3A4 inhibitors or inducers
  • Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
  • Acute or chronic liver, pancreatic or severe renal disease
  • History of pancreatitis or chronic pancreatitis.
  • Impaired cardiac function
  • No evidence of active graft vs host and <3mo since Stem Cell Transplant
  • Total body irradiation (TBI) or craniospinal radiation therapy <6months
  • Hypersensitivity to the active ingredient or any of the excipients including lactose.
  • Other protocol-defined inclusion/exclusion criteria.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Children's Oncology Group

Innovative Therapies for Children with Cancer

Novartis PharmaceuticalsStudy Director

Novartis PharmaceuticalsPh: 1-888-669-6682

Trial Sites

U.S.A.
California
  Loma Linda
 Loma Linda University Health Oncology
 Contact Person Ph: 909-558-7428
 Albert KheradpourPrincipal Investigator
  Los Angeles
 Children's Hospital Los Angeles
 Contact Person Ph: 323-361-2225
 Cecilia H. FuPrincipal Investigator
  Madera
 Children's Hospital Central California
 Contact Person Ph: 559-353-5480
 J Daniel OzeranPrincipal Investigator
  Palo Alto
 Lucile Salter Packard Children's Hospital at Stanford
 Contact Person Ph: 650-723-5117
 Neyssa MarinaPrincipal Investigator
  San Diego
 Kaiser Permanente - California Southern Onc
 Contact Person Ph: 323-783-5307
 Robert CooperPrincipal Investigator
Florida
  Fort Myers
 Lee Cancer Care of Lee Memorial Health System
 Contact Person Ph: 239-343-5333
 Emad SalmanPrincipal Investigator
  Gainesville
 UF Health Cancer Center
 Contact Person Ph: 352-273-9120
 William SlaytonPrincipal Investigator
  Orlando
 Nemours Children's Hospital
 Contact Person Ph: 407-234-1740
 Ramamoorthy NagasubramanianPrincipal Investigator
  West Palm Beach
 Kaplan Cancer Center at St. Mary's Medical Center
 Virupakshapu Narayana-GowdaPrincipal Investigator
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Contact Person Ph: 312-227-4855
 Nobuko HijiyaPrincipal Investigator
Indiana
  Indianapolis
 Riley Hospital for Children Oncology
 Contact Person Ph: 317-948-1269
 Robert FallonPrincipal Investigator
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Contact Person Ph: 410-955-8817
 Patrick BrownPrincipal Investigator
Minnesota
  Minneapolis
 University of Minnesota Medical Center, Fairview Oncology
 Peter GordonPrincipal Investigator
Mississippi
  Jackson
 University of Mississippi Medical Center Peds Heme/Onc
 Contact Person Ph: 601-984-5220
 Gail MegasonPrincipal Investigator
North Carolina
  Chapel Hill
 UNC Chapel Hill
 Contact Person Ph: 919-966-0985
 Stuart GoldPrincipal Investigator
Ohio
  Cleveland
 Rainbow Babies & Children's Hospital RB&C 340
 Contact Person Ph: 216-844-3345
 Yousif MatloubPrincipal Investigator
  Columbus
 Nationwide Children's Hospital
 Contact Person Ph: 614-722-4360
 Mark RanalliPrincipal Investigator
Tennessee
  Memphis
 St. Jude Children's Research Hospital
 Contact Person Ph: 901-595-4616
 Patrick CampbellPrincipal Investigator
Texas
  Austin
 Dell Children's Medical Center of Central Texas
 Sharon LockhartPrincipal Investigator
  Dallas
 Children's Medical Center of Dallas Oncology
 Contact Person Ph: 214-648-2912
 Theodore LaetschPrincipal Investigator
  Fort Worth
 Cook Children's Medical Center - Fort Worth
 Contact Person Ph: 682-885-4007
 Kenneth HeymPrincipal Investigator
Wisconsin
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael BurkePrincipal Investigator
Austria
  Vienna
 Novartis Investigative Site
Belgium
  Gent
 Novartis Investigative Site
Canada
  Quebec
 Novartis Investigative Site
France
  Bordeaux
 Novartis Investigative Site
  Lille
 Novartis Investigative Site
  Lyon Cedex 08
 Novartis Investigative Site
  Poitiers
 Novartis Investigative Site
  Strasbourg
 Novartis Investigative Site
Hungary
  Budapest
 Novartis Investigative Site
Italy
  Genova
 Novartis Investigative Site
  Monza
 Novartis Investigative Site
  Napoli
 Novartis Investigative Site
  Padova
 Novartis Investigative Site
  Torino
 Novartis Investigative Site
Japan
  Kyoto-city
 Novartis Investigative Site
  Saitama
 Novartis Investigative Site
  Shinjuku-ku
 Novartis Investigative Site
  Shizuoka
 Novartis Investigative Site
  Yokohama-city
 Novartis Investigative Site
Netherlands
  Amsterdam
 Novartis Investigative Site
  Groningen
 Novartis Investigative Site
  Rotterdam
 Novartis Investigative Site
Republic of Korea
  Seoul
 Novartis Investigative Site
Russia
  Moskow
 Novartis Investigative Site
Spain
  Barcelona
 Novartis Investigative Site
  Madrid
 Novartis Investigative Site
Thailand
  Bangkok
 Novartis Investigative Site
  Muang
 Novartis Investigative Site
Turkey
  Ankara
 Novartis Investigative Site
  Istanbul
 Novartis Investigative Site
United Kingdom
  Bath
 Novartis Investigative Site
  Birmingham
 Novartis Investigative Site
  London
 Novartis Investigative Site
  Newcastle Upon Tyne
 Novartis Investigative Site
  Sutton
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01844765
ClinicalTrials.gov processed this data on December 23, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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