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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
Not Enrolling
Both
Anaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer

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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 GeneralBoston, Massachusetts  02114
Fox Chase Cancer Center Fox Chase Cancer (2)Philadelphia, Pennsylvania  19111-2497
University of Utah / Huntsman Cancer Institute HuntsmanSalt Lake City, Utah  84103