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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumors Characterized by Genetic Abnormalities of ALK

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Trial Information

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)


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

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

Name

Location

University of Texas Southwestern Medical Center UTSWDallas, Texas  75390-9034
University of Colorado Colorado UnivAurora, Colorado  80045
Massachusetts General Hospital Mass GeneralBoston, Massachusetts  02114
Memorial Sloan Kettering Cancer Center MSKNew York, New York  10021
Fox Chase Cancer Center Fox Chase Cancer (2)Philadelphia, Pennsylvania  19111-2497
University of Utah / Huntsman Cancer Institute HuntsmanSalt Lake City, Utah  84103
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SCSeattle, Washington  98109-1023
University of California at Los Angeles UCLA LeConte LocationLos Angeles, California  90095