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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the proper dose of LDK378 to be used in clinical trials

Outcome Time Frame:

48 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLDK378X2101

NCT ID:

NCT01283516

Start Date:

January 2011

Completion Date:

March 2015

Related Keywords:

• Tumors Characterized by Genetic Abnormalities of ALK
• ALK inhibitor,
• NSCLC,
• LDK378,
• genetic abnormalities
• Congenital Abnormalities
• Lymphoma