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Ceritinib Rare Indications Study in ALK+ Tumors

NCT02465528 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-12-27

Study results available
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Summary

This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).

Conditions

  • Tumors With Aberrations in ALK
  • Anaplastic Large Cell Lymphoma
  • Inflammatory Myofibroblastic Tumor
  • Glioblastoma

Interventions

DRUG

Ceritinib (LDK378)

Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-06
Primary Completion
2018-08-20
Completion
2018-08-20

Countries

  • Czechia
  • Denmark
  • France
  • Israel
  • Italy
  • South Korea
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
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 NCT02465528 on ClinicalTrials.gov