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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

  Show 25 Study Locations
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 19, 2013