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A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)

This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283516
First received: January 24, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess the safety and efficacy of LDK378 in patients with genetic abnormalities in anaplastic lymphoma kinase (ALK)


Condition Intervention Phase
Tumors Characterized by Genetic Abnormalities of ALK
 Drug: LDK378
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determination of the proper dose of LDK378 to be used in clinical trials [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Type and category of study drug related adverse events [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]
  • Absorption and plasma concentrations of LDK378 [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Overall response rate of tumor [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 370
Study Start Date: January 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDK378 previously treated with ALK
NSCLC previously treated with an ALK inhibitor
 Drug: LDK378
Experimental: LDK378 not previously treated with ALK
NSCLC not previously treated with an ALK inhibitor
 Drug: LDK378
Experimental: LDK378 on other ALK + tumors
Other tumors that are ALK positive other than NSCLC
 Drug: LDK378

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Tumor must be confirmed to be ALK positive

Exclusion Criteria:

  • Pregnant
  • Active pancreatitis
  • Active or chronic liver disease

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283516

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, California
University of California at Los Angeles UCLA LeConte Location Withdrawn
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Colorado Univ Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelsey Brunkow     +1 720 848 0655     kelsey.brunkow@ucdenver.edu    
Principal Investigator: David Ross Camidge            
United States, Massachusetts
Massachusetts General Hospital Mass General Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cory Furguson     617-724-1223     cferguson2@partners.org    
Principal Investigator: Alice Shaw            
United States, New York
Memorial Sloan Kettering Cancer Center MSK Recruiting
New York, New York, United States, 10021
Contact: Murtaza Mehdi     646-227-2131     mehdim@mskcc.org    
Principal Investigator: Gregory J. Riely            
United States, Pennsylvania
Fox Chase Cancer Center Fox Chase Cancer (2) Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Trina Greer     215-214-4297     trina.greer@fccc.edu    
Principal Investigator: Ranee Mehra            
United States, Texas
University of Texas Southwestern Medical Center UTSW Withdrawn
Dallas, Texas, United States, 75390-8527
United States, Utah
University of Utah / Huntsman Cancer Institute Huntsman Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Jessica Moehle     801-585-0443     jessica.moehle@hci.utah.edu    
Principal Investigator: Sunil Sharma            
United States, Washington
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SC Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Reina Hibbert     206-288-6272     rhibbert@seattlecca.org    
Principal Investigator: Laura Chow            
Australia, New South Wales
Novartis Investigative Site Withdrawn
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Novartis Investigative Site Recruiting
Melbourne, Victoria, Australia, 3002
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Köln, Germany, 50924
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Italy
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Rozzano, MI, Italy, 20089
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 110 744
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
New Zealand
Novartis Investigative Site Withdrawn
Grafton, Auckland, New Zealand
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Barcelona, Cataluna, Spain, 08035
United Kingdom
Novartis Investigative Site Recruiting
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site Recruiting
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01283516     History of Changes
Other Study ID Numbers: CLDK378X2101, 2010-019827-70
Study First Received: January 24, 2011
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Research Ethics Committee
Spain: Ministerio de Sanidad y Politico Social-Agencia Espanola de Medicamentos y Productos Sanitarios
Germany:The Federal Institute for Drugs and Medical Devices (BfArM)
Belgium: Belgian Federal Public Service
Netherlands: Dutch Healthcare Inspectorate (IGZ)
Italy: Ministry of Labor, Health & Social Affairs, Department of Innovation
Australia: Therapeutic Goods Administration
China: State Food & Drug Administration (SFDA)
Thailand: Food & Drug Administration
New Zealand: New Zealand Medicines & Medical Devices Safe Authority (MedSafe)
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Novartis:
ALK inhibitor,
NSCLC,
LDK378,
genetic abnormalities

Additional relevant MeSH terms:
Congenital Abnormalities
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013