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Expanded Access to Ensartinib for Participants With ALK+ NSCLC

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ClinicalTrials.gov Identifier: NCT04146571
Expanded Access Status : Available
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Xcovery Holding Company, LLC

Brief Summary:
This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer ALK Gene Rearrangement Positive Drug: Ensartinib

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Intermediate-Size Patient Population Protocol



Intervention Details:
  • Drug: Ensartinib
    Oral, ALK inhibitor
    Other Names:
    • X-396
    • X396

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Adult patients (>18 years-of-age) with advanced ALK-positive NSCLC as determined by an FDA approved test.
  2. Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
  3. Informed consent must be provided by each patient.
  4. Patient is not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib.
  5. Ability to swallow and retain oral medication.
  6. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.
  7. Adequate organ system function.
  8. Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids. ALK-positive patients with untreated CNS lesions may be allowed to enroll as long as the patients are asymptomatic with respect to the CNS metastases and do not require systemic corticosteroids or anticonvulsants.

Exclusion Criteria:

  1. Patients currently receiving cancer therapy.
  2. Use of an investigational or targeted drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib. A minimum of 10 days between termination of the treatment and administration of ensartinib is required. However, in the case of ALK TKIs, a 2-day window between termination of the TKI and the start of ensartinib is allowed. In addition, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.
  3. Any major surgery or immunotherapy within the last 21 days (focal radiation does not require a washout period; ≥4 weeks for whole brain radiotherapy). Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
  4. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib (e.g., crizotinib) or to the active ingredient of ensartinib or to tartrazine, a dye used in the ensartinib 100 mg capsules.
  5. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.
  6. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib.
  7. Clinically significant cardiovascular disease.
  8. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  10. Have a history or the presence at baseline of pulmonary interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis.
  11. Females who are pregnant or breastfeeding.
  12. Patient with any concurrent condition or receiving any concurrent medication that, in the investigator's opinion, would impart excessive risk associated with study participation or otherwise make it inappropriate for the patient to participate.

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): NCT04146571


Contacts
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Contact: Allison K Holzhausen 5618359356 ext 206 allison@xcovery.com
Contact: Kimberly Harrow 5618359356 ext 200 kim@xcovery.com

Locations
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United States, California
City of Hope National Med Ctr
Duarte, California, United States, 91010
Contact: Thomas Fok    626-218-4438    tfok@coh.org   
Principal Investigator: Karen Reckamp, M.D.         
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Contact: Gina Tse    323-865-3962    tse_g@med.usc.edu   
Principal Investigator: Jorge Nieva, MD         
Stanford University
Stanford, California, United States, 94305
Contact: Richard Quick    650-723-2983    richardq@stanford.edu   
Principal Investigator: Heather Wakelee, M.D.         
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Contact: Trevor Mamplata    813-745-1036    trevor.mamplata@moffitt.org   
Principal Investigator: Alberto Chiappori, MD         
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Contact: Sonja Skeete    301-319-4599    sonja.t.skeete.ctr@mail.mil   
Principal Investigator: Karen Zeman, M.D.         
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37240
Contact: Rhonda Combs    800-811-8480    cip@vanderbilt.edu   
Principal Investigator: Leora Horn, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Ctr
Madison, Wisconsin, United States, 53792
Contact: Alex Kaminski    608-262-8665    agkaminski@wisc.edu   
Principal Investigator: Ticiana Leal, M.D.         
Sponsors and Collaborators
Xcovery Holding Company, LLC

Publications of Results:
Other Publications:
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Responsible Party: Xcovery Holding Company, LLC
ClinicalTrials.gov Identifier: NCT04146571     History of Changes
Other Study ID Numbers: X396-CLI-205
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Keywords provided by Xcovery Holding Company, LLC:
ensartinib
X-396
X396
anaplastic lymphoma kinase
ALK+
ALK positive
NSCLC
Non-Small Cell Lung Cancer
ALK inhibitor
carcinoma
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ensartinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action