A Phase Ib, Open-label, Dose Escalation Study of LDK378 and AUY922 in Patients With ALK-rearranged Non-small Cell Lung Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer
Both
Anaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer
Trial Information
A Phase Ib, Open-label, Dose Escalation Study of LDK378 and AUY922 in Patients With ALK-rearranged Non-small Cell Lung Cancer
Inclusion Criteria:
- locally advanced or metastatic NSCLC
- tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by
FISH
- disease that can be evaluated by RECIST v1.1 and measurable disease
Exclusion Criteria:
- central nervous system (CNS) metastases that are symptomatic or require increasing
steroids or CNS-directed therapy
- clinically significant cardiac dysfunction
- inadequate end organ function as defined by specified laboratory values
- use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot
be discontinued at least 1 week prior to start of treatment
- use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that canno be
discontinued at least 1 week prior to start of treatment
- clinically significant, uncontrolled impaired gastrointestinal function or GI disease
- prior treatment with a HSP90 inhibitor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence rate of Dose Limiting Toxicities (DLT)
Outcome Description:
cycle = within the first 28 days of patient's first dose
Outcome Time Frame:
up to day 28 after the patient's first dose
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLDK378X2102
NCT ID:
NCT01772797
Start Date:
March 2013
Completion Date:
May 2015
Related Keywords:
- Anaplastic Lymphoma Kinase (ALK)
- Non-Small Cell Lung Cancer
- anaplastic lymphoma kinase, ALK-rearranged lung cancer, non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Lymphoma
Name | Location |
|---|---|
| University of Colorado Dept. of Anschutz Cancer (3) | Aurora, Colorado 80045 |
| Massachusetts General Hospital Mass General | Boston, Massachusetts 02114 |
| Fox Chase Cancer Center Fox Chase Cancer (2) | Philadelphia, Pennsylvania 19111-2497 |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City, Utah 84103 |
