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A Study of Oral LOXO-292 in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

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Trial Profile

A Study of Oral LOXO-292 in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Jun 2024

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At a glance

  • Drugs Selpercatinib (Primary)
  • Indications Adenocarcinoma; Adrenal cancer; Advanced breast cancer; Carcinoid tumour; Carcinoma; Cholangiocarcinoma; Colon cancer; Large cell carcinoma; Medullary thyroid cancer; Neuroendocrine carcinoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Paraganglioma; Rectal cancer; Salivary gland cancer; Sarcoma; Skin cancer; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms LIBRETTO-001
  • Sponsors Loxo Oncology
  • Most Recent Events

    • 12 Jun 2024 According to a Food and Drug Administration media release, based on results from LIBRETTO-001 trial and LIBRETTO-121, the FDA has granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
    • 04 Jun 2024 Results (n=23; data cut-off: 13 Jan 2023) assessing if selpercatinib was effective in non-MTC, RET mutation positive tumors and whether certain RET mutations demonstrated better activity presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 20 Jan 2024 Results(n=52, data cut-off: 13Jan2023) presented at the 2024 Gastrointestinal Cancers Symposium
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