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Managed Access Programs for LDK378, Ceritinib

Primary Purpose

Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
ceritinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Anaplastic Lymphoma Kinase (ALK)- Positive Tumors focused on measuring MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

  1. The patient is diagnosed with ALK-positive tumor.
  2. The patient has been previously pre-treated with ALK inhibitor or naive.
  3. The patient has progression of disease at screening or is intolerant to prior therapy and does not qualify or have access to LDK378 through a clinical trial.
  4. The patient has a performance status (WHO) of 0-2.
  5. The following laboratory criteria have been met:

    • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
    • Hemoglobin (Hgb) ≥ 8 g/dL
    • Platelets ≥75 x 10^9/L
    • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who may be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
    • Aspartate transaminase (AST) ≤ 3.0 x ULN, except for patients with liver metastasis, who are only included if AST ≤ 5.0 x ULN;
    • Alanine transaminase (ALT) ≤3.0 x ULN, except for patients with liver metastasis, who are only included if ALT ≤ 5.0 x ULN;
    • alkaline phosphatase (ALP) ≤ 5.0 x ULN
    • Serum creatinine <1.5 mg/dL and or Calculated creatinine clearance (CrCL) (using Cockcroft-Gault formula) ≥ 30 mL/min
    • Serum amylase ≤ 2 x ULN
    • Serum lipase ≤ ULN
    • Fasting plasma glucose ≤175 mg/dL (≤9.8 mmol/L)
  6. Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of ceritinib:

    • Potassium
    • Magnesium
    • Phosphorus
    • Total calcium (corrected for serum albumin) Written patient informed consent must be obtained prior to start of treatment.

Exclusion Criteria:

Patients eligible for this Treatment Plan must not meet any of the following criteria:

  1. A history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  2. Other concurrent severe, acute, or chronic and/or uncontrolled medical conditions (e.g. diabetes mellitus or psychiatric conditions or laboratory abnormalities uncontrolled heart disease in the last 6 months, active or uncontrolled infection) that, in the opinion of the treating physician, could cause unacceptable safety risks, interfere with the interpretation of the results or compromise compliance with the treatment plan.
  3. Patient who has received thoracic radiotherapy to lung fields ≤4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy ≤2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting study treatment is allowed.
  4. Known history of interstitial lung disease or interstitial pneumonitis including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention).
  5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:

    • Unstable angina within 6 months prior to screening.
    • Myocardial infarction within 6 months prior to screening.
    • History of documented congestive heart failure (New York Heart Association functional classification III-IV).
    • Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to screening.
    • Ventricular arrhythmias
    • Supraventricular and nodal arrhythmias not controlled with medication.
    • Other cardiac arrhythmia not controlled with medication.
    • Corrected QT (QTcF) >470 ms using Fridericia's correction on the screening ECG (as mean of triplicate ECGs).
  6. Known hypersensitivity to any excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  7. Impaired GI function or GI disease that may significantly alter absorption of LDK378 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  8. Patient must not be participating in other ongoing trials, or ALK inhibitors trials or other compassionate use programs. Patients eligible for this program are also ineligible for other ALK inhibitors trials.
  9. Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with LDK378 and for the duration of the program:

    • Strong inhibitors or strong inducers of CYP3A4/5
    • Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5 and/or CYP2C9
    • Medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
    • Receiving treatment with warfarin sodium (Coumadin) or any other coumadinderived anti-coagulant
    • Receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non- CNS), dose must have been stabilized (or decreasing) for at least 5 days before first dose of treatment.
    • Patient has had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to starting treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can receive treatment ≥1 week after these procedures
    • Receiving enzyme-inducing anticonvulsives that cannot be discontinued at least 1 week before first dose of treatment, and for the duration of the treatment. Patients on non-enzyme-inducing anticonvulsants are eligible.
  10. Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after the last dose of program drug. Patient should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
  11. Pregnant or nursing (lactating) women
  12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping medication. Highly effective contraception methods include:

    • Total abstinence (no sexual relations), when this is in line with your preferred and usual lifestyle. Periodic abstinence like calendar, ovulation, symptothermal, postovulation methods, and withdrawal are not acceptable methods of contraception.
    • Female sterilization, when you have been already surgically sterilized prior to the program by surgical removal of both ovaries (woman's reproductive system that stores and releases eggs for fertilization and produces female sex hormones), total hysterectomy (surgical removal of the uterus and cervix), or tubal ligation (getting your "tubes tied") at least six weeks before taking program treatment.
    • Your male partner has already been sterilized at least 6 months prior to screening with the appropriate documentation. The sterilized male partner should be your sole partner.
    • Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception (in case of oral contraception you should have been using the same pill on a stable dose for a minimum of 3 months before taking program treatment).

In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2021
    Last Updated
    August 31, 2023
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05100134
    Brief Title
    Managed Access Programs for LDK378, Ceritinib
    Official Title
    Managed Access Programs for LDK378, Ceritinib
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
    Detailed Description
    CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors. CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity. CLDK378A2003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)
    Keywords
    MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ceritinib
    Other Intervention Name(s)
    LDK378
    Intervention Description
    Patients receive ceritinib

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. Managed Access provision is allowed per local laws/regulations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Novartis Pharmaceuticals
    Phone
    1-888-669-6682
    Email
    novartis.email@novartis.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Novartis Pharmaceuticals
    Phone
    +41613241111
    Email
    novartis.email@novartis.com

    12. IPD Sharing Statement

    Learn more about this trial

    Managed Access Programs for LDK378, Ceritinib

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