NCT01772797

Brief Summary

The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 19, 2020

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

January 17, 2013

Last Update Submit

December 16, 2020

Conditions

Anaplastic Lymphoma Kinase (ALK)Non-small Cell Lung Cancer

Keywords

anaplastic lymphoma kinase, ALK-rearranged lung cancer, non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of Dose Limiting Toxicities (DLT)

    cycle = within the first 28 days of patient's first dose

    up to day 28 after the patient's first dose

Secondary Outcomes (15)

  • Number of patients with adverse events

    30 months

  • Changes in laboratory values

    30 months

  • Assessments of electrocardiograms

    30 months

  • Assessments of dose interruptions, reductions, and dose intensity

    30 months

  • Plasma PK parameter of LDK378 and AUY922: Tmax

    30 months

  • +10 more secondary outcomes

Study Arms (1)

LDK378 and AUY922

EXPERIMENTAL
Drug: LDK378Drug: AUY922

Interventions

LDK378DRUG

LDK378 is a capsule to be taken daily by mouth.

LDK378 and AUY922
AUY922DRUG

AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.

LDK378 and AUY922

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor
  • 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

You may not qualify if:

  • central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease
  • history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
  • 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 cannot 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
  • radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
  • pregnant or nursing women
  • history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Colorado Dept. of Anschutz Cancer (3)

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital Mass General

Boston, Massachusetts, 02114, United States

Location

Fox Chase Cancer Center Fox Chase Cancer (2)

Philadelphia, Pennsylvania, 19111-2497, United States

Location

University of Utah / Huntsman Cancer Institute Huntsman

Salt Lake City, Utah, 84103, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ceritinib5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 19, 2020

Record last verified: 2016-09

Locations

US(4)SG(1)IT(1)ES(1)AU(1)