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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: January 24, 2011
Last updated: February 7, 2014
Last verified: February 2014

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:

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 ]

Enrollment: 303
Study Start Date: January 2011
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2013 (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


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

Inclusion Criteria:

• Tumor must be confirmed to be ALK positive by FISH

Exclusion Criteria:

  • Pregnant
  • Active pancreatitis
  • Active or chronic liver disease

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 21 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
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: Federal Agency for Medicinal Products and Health Products
The Netherlands: Dutch Healthcare Inspectorate (IGZ)
Italy: Ministry of Labor, Health & Social Affairs, Department of Innovation
Australia: Therapeutic Goods Administration
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Novartis:
ALK inhibitor,
genetic abnormalities

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

ClinicalTrials.gov processed this record on July 31, 2014