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
18 Years
N/A
Open (Enrolling)
Both
Tumors Characterized by Genetic Abnormalities of ALK
Both
Tumors Characterized by Genetic Abnormalities of ALK
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 UTSW | Dallas, Texas 75390-9034 |
| University of Colorado Colorado Univ | Aurora, Colorado 80045 |
| Massachusetts General Hospital Mass General | Boston, Massachusetts 02114 |
| Memorial Sloan Kettering Cancer Center MSK | New York, New York 10021 |
| Fox Chase Cancer Center Fox Chase Cancer (2) | Philadelphia, Pennsylvania 19111-2497 |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City, Utah 84103 |
| Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SC | Seattle, Washington 98109-1023 |
| University of California at Los Angeles UCLA LeConte Location | Los Angeles, California 90095 |
