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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)

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ClinicalTrials.gov Identifier: NCT02186821
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Tumors With Aberrations in ALK or ROS1 Drug: Ceritinib (LDK378) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 17, 2014
Primary Completion Date : September 26, 2016
Study Completion Date : December 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ceritinib
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186821


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Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02186821     History of Changes
Other Study ID Numbers: CLDK378AUS23
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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