Last updated on June 2020

A Study to Test the Safety of the Investigational Drug Selitrectinib 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: Astrocytoma | Biliary Tract Cancer | Nevi and Melanomas | Intestinal Cancer | Nerve Tissue | Nerve Sheath Tumors | Glioblastoma Multiforme | Uterine Cancer | gastrointestinal stromal tumor | Thyroid Adenoma | Invasive Ductal Breast Carcinoma | gliomas pontine | Colon cancer; rectal cancer | Colorectal Cancer | Renal Cell Carcinoma | Pancreatic Cancer | melanoma | Brain Cancer | Thyroid Cancer | Skin Carcinoma | Sarcoma (Pediatric) | Respiratory Tract Neoplasm | Colon Cancer Screening | Non-Small Cell Lung Cancer | Breast Secretory Carcinoma | Recurrent Ovarian Cancer | Malignant neoplasm of brain | Bronchial Neoplasm | Brain Tumor | Malignant Melanoma | Brain Tumor (Pediatric) | Solid Tumors Harboring NTRK Fusion | skin cancer | Islet Ce417ll Cancer | Soft Tissue Sarcoma | Central Nervous System Neoplasms | Sarcoma | Renal Cell Cancer | Lung Neoplasm | Ovarian Cancer | Bronchogenic Carcinoma | Cholangiocarcinoma | Biliary neoplasm | Thoracic Neoplasms | Fibrosarcoma | Mesoblastic Nephroma | Infantile Fibrosarcoma | Head and Neck Squamous Cell Carcinoma | Metastatic Melanoma | Neoplasms | Urothelial Tract Cancer | Bile duct carcinoma | Lung Cancer | salivary gland 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 selitrectinib
  • Ability to receive study drug orally or by enteral administration

Exclusion Criteria:

  • Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, TPX-0005). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
  • Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, 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 selitrectinib or Ora-Sweet SF and OraPlus for patients receiving liquid formulation.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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