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A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

NCT01283516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2019-03-15

Study results available
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Summary

This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).

Conditions

  • Tumors Characterized by Genetic Abnormalities of ALK

Interventions

DRUG

LDK378

LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-24
Primary Completion
2016-05-03
Completion
2016-05-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283516 on ClinicalTrials.gov