Clinical Trials /

Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

NCT02186821

Description:

The purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Related Conditions:
  • Cancer
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Ceritinib (LDK378)</span> for Patients Whose Tumors Have Aberrations in <span class="go-doc-concept go-doc-biomarker">ALK</span> or <span class="go-doc-concept go-doc-biomarker">ROS1</span> (SIGNATURE)

Title

  • Brief Title: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02186821

    ORG ID: CLDK378AUS23

    Trial Conditions

    Tumors With Aberrations in ALK or ROS1

    Trial Interventions

    Drug Synonyms Arms
    Ceritinib (LDK378) Ceritinib (LDK378)

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Ceritinib (LDK378) Experimental 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. Ceritinib (LDK378)

    Eligibility 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Clinical benefit rate associated with ceritinib treatment

    Secondary Outcome Measures

    Overall Response (OR) of Partial Response (PR) or greater

    Progression-Free Survival (PFS)

    Overall Survival (OS)

    Duration of Response (DOR)

    Safety and tolerability

    Trial Keywords

    hematological malignancy

    solid tumor malignancy

    mutation

    translocation

    rearrangement

    amplification

    ALK

    ROS1

    NSCLC

    B-cell lymphoma