Last updated on January 2020

A Study to Test the Safety of the Investigational Drug Loxo-195 in Children and Adults That May Treat Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Thyroid Adenoma | Colorectal Cancer | Lung Neoplasm | Ovarian Cancer | Invasive Ductal Breast Carcinoma | Head and Neck Squamous Cell Carcinoma | Biliary neoplasm | Nerve Sheath Tumors | Bronchial Neoplasm | Pancreatic Cancer | Central Nervous System Neoplasms | Thoracic Neoplasms | Fibrosarcoma | Neoplasms | Intestinal Cancer | Renal Cell Carcinoma | Uterine Cancer | Breast Secretory Carcinoma | Solid Tumors Harboring NTRK Fusion | Bronchogenic Carcinoma | Respiratory Tract Neoplasm | Skin Carcinoma | salivary gland cancer | Glioblastoma Multiforme | melanoma | Infantile Fibrosarcoma | gastrointestinal stromal tumor | Nerve Tissue | Malignant neoplasm of brain | Astrocytoma | Nevi and Melanomas | Cholangiocarcinoma | gliomas pontine | Non-Small Cell Lung Cancer | Mesoblastic Nephroma | Bile duct carcinoma | Sarcoma | skin cancer
  • Age: Between 1 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit.
  • A solid tumor diagnosis in the setting of:
  • a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
  • b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
  • c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
  • NTRK gene fusions will be identified in a CLIA-certified (or equivalent) laboratory. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3.
  • Performance Status: Eastern Cooperative Oncology Group (ECOG) score 3 (age 16 years) or Lansky Performance Score (LPS) 40% (age < 16 years). If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Score (KPS) (age 16 years) or LPS (age < 16 years) 50%.
  • Life expectancy > 4 weeks.
  • Adequate hematologic, hepatic and renal function.
  • Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of LOXO-195
  • Ability to receive study drug orally or by enteral administration

Exclusion Criteria:

  • Concurrent treatment with a strong CYP3A4 inhibitor or inducer or drugs associated with QT prolongation.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
  • Major surgery within 7 days of enrollment
  • Uncontrolled systemic bacterial, fungal or viral infection.
  • Pregnancy or lactation.
  • Known hypersensitivity to LOXO-195 or Ora-Sweet SF and OraPlus for patients receiving liquid formulation.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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