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Protocol No. UW19085

Principal Investigator Leal, Ticiana

Phase N/A

Age Group Adult

Scope National

Sponsor Type Industry

Title Expanded Access Intermediate-Size Patient Population Protocol for Ensartinib (X-396)

Objective You are being invited to take part in this treatment because you have advanced cancer and the standard drugs to treat your disease are no longer effective or there is not an effective treatment known for your type of cancer or you are currently taking ensartinib on a clinical trial. "Investigational" means that ensartinib has not been approved by the FDA for use outside of clinical studies

Ensartinib 225 mg by mouth daily

Description Expanded Access Intermediate-Size Patient Population Protocol

Key Eligibility
  • At least 18 years of age or older with advanced ALK-positive NSCLC as determined by an FDA approved test
  • ECOG PS 0-1
  • Not eligible or does not have access for participation in any of the other ongoing clinical trials for ensartinib
  • Ability to swallow and retain oral medication
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Adequate organ system function as defined by the protocol
  • Treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids (i.e.,stable or decreasing low-dose corticosteroids are allowed, as are stable anticonvulsants). 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
  • Currently receiving cancer therapy (i.e., chemotherapy, radiation therapy,immunotherapy, biologic therapy, hormonal therapy [with the exception of luteinizing hormone releasing hormone (LHRH) agonists for prostate cancer], surgery and/or tumor embolization)
  • Any major surgery or immunotherapy within the last 21 days (focal radiation does no require a washout period; greater than or equal to 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
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib
  • Clinically significant cardiovascular disease as defined by the protocol
  • Congestive heart failure (New York Heart Class III or IV), Cardiomyopathy, Arrhythmia or conduction abnormality requiring medication, Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction, or Cerebrovascular accident or transient ischemia within 12 months prior to day 1
  • 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
  • History or the presence at baseline of pulmonary interstitial lung disease, drugrelated pneumonitis, or radiation pneumonitis
  • Can not be pregnant or breastfeeding

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics