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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01283516
First received: January 24, 2011
Last updated: February 7, 2014
Last verified: February 2014

January 24, 2011
February 7, 2014
January 2011
August 2013   (final data collection date for primary outcome measure)
Determination of the proper dose of LDK378 to be used in clinical trials [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01283516 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)
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)

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors Characterized by Genetic Abnormalities of ALK
Drug: LDK378
  • Experimental: LDK378 previously treated with ALK
    NSCLC previously treated with an ALK inhibitor
    Intervention: Drug: LDK378
  • Experimental: LDK378 not previously treated with ALK
    NSCLC not previously treated with an ALK inhibitor
    Intervention: Drug: LDK378
  • Experimental: LDK378 on other ALK + tumors
    Other tumors that are ALK positive other than NSCLC
    Intervention: Drug: LDK378
Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27;370(13):1189-97. doi: 10.1056/NEJMoa1311107.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
303
August 2015
August 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   United Kingdom
 
NCT01283516
CLDK378X2101, 2010-019827-70
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP