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Trial record 1 of 1 for:    NCT02186821
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Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) (SIGNATURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02186821
First received: July 3, 2014
Last updated: November 27, 2016
Last verified: November 2016
  Purpose
The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Condition Intervention Phase
Tumors With Aberrations in ALK or ROS1
Drug: Ceritinib (LDK378)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module - 7 Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical benefit rate associated with ceritinib treatment [ Time Frame: 16 weeks ]
    For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR or PR or SD ≥ 16 weeks. For hematologic tumors, other appropriate hematological response criteria will apply


Secondary Outcome Measures:
  • Overall Response (OR) of Partial Response (PR) or greater [ Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months ]
    For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors, other appropriate hematological response criteria will apply

  • Progression-Free Survival (PFS) [ Time Frame: every 8 weeks until death, assessed up to 24 months ]
    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

  • Overall Survival (OS) [ Time Frame: every 8 weeks until death, assessed up to 36 months ]
    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause

  • Duration of Response (DOR) [ Time Frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months ]
    Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause

  • Safety and tolerability [ Time Frame: baseline up to 30 days after last study treatment ]
    Incidence of AEs, SAEs, changes from baseline in vital signs, laboratory test results (hematology, biochemistry), ECG, and cardiac imaging will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE), v4.03


Enrollment: 45
Study Start Date: September 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceritinib (LDK378)
Ceritinib will be dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Drug: Ceritinib (LDK378)
Ceritinib will be dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and is in need of treatment because of radiologic progression or relapse.
  • Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH are allowed.
  • Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  • Patient has progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Exclusion Criteria:

  • Patient has received prior treatment with ceritinib.
  • Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  • Patient has received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186821

  Show 26 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02186821     History of Changes
Other Study ID Numbers: CLDK378AUS23
Study First Received: July 3, 2014
Last Updated: November 27, 2016

Keywords provided by Novartis:
hematological malignancy
solid tumor malignancy
mutation
translocation
rearrangement
amplification
ALK
ROS1
NSCLC
B-cell lymphoma

Additional relevant MeSH terms:
Ceritinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 25, 2017