Exploring the path to selective TRK inhibition

Larotrectinib (LOXO-101) Trials

Call us to find out more information about TRK fusion testing, larotrectinib (LOXO-101), and clinical trial access. Clinical Trial Hotline 1-855-NTRK-123

Loxo Oncology’s lead investigational agent for TRK inhibition, larotrectinib (LOXO-101)

Loxo Oncology’s lead therapy in clinical development, larotrectinib (LOXO-101), is an oral and selective inhibitor of tropomyosin receptor kinase (TRK), a family of signaling proteins that play an important role in cellular communication and tumor growth.

Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally bound to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Patients with advanced cancer who seek out tumor profiling or comprehensive cancer genetic testing may discover that their tumor harbors a TRK fusion, as this genetic event has been described across many tumor types, including: 

  • Acute myeloid leukemia
  • Astrocytoma
  • Brain low-grade glioma
  • Breast cancer
  • Colorectal cancer
  • Congenital mesoblastic nephroma
  • Gastrointestinal stromal tumors
  • Glioblastoma multiforme
  • Head and neck squamous cell cancer
  • Infantile fibrosarcoma
  • Intrahepatic cholangiocarcinoma
  • Lung cancer
  • Mammary analog secretory carcinoma of salivary gland origin
  • Melanoma
  • Sarcoma
  • Secretory breast cancer
  • Thyroid cancer

Larotrectinib (LOXO-101) was designed to target TRK, turning off the signaling pathway that allows TRK fusion cancers to grow. Larotrectinib (LOXO-101) was developed in partnership with Array BioPharma.

Both the FDA and EMA have granted orphan drug designation for larotrectinib (LOXO-101) for treatment of patients with soft tissue sarcoma.

The following larotrectinib (LOXO-101) clinical trials are actively recruiting:

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NCT02576431 | Study of larotrectinib (LOXO-101) in Subjects With NTRK Fusion Positive Solid Tumors

Global, multicenter, single-arm, open-label, Phase 2 basket trial in patients with solid tumors with a fusion of NTRK1, NTRK2, or NTRK3.

Loxo Oncology collaborates with the clinical, laboratory, and molecular pathology communities in both academia and industry to help ensure that patients with TRK fusions and their treating physicians are notified about the larotrectinib (LOXO-101) Phase 2 clinical trial to help integrate a trial recruitment mechanism for appropriate patients into routine clinical practice.

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NCT02637687 | Oral TRK Inhibitor larotrectinib (LOXO-101) for Treatment of Advanced Pediatric Solid or Primary Central Nervous System Tumors

This Phase 1/2 clinical trial is a multicenter, open-label trial in pediatric patients with advanced solid or primary central nervous system tumors. The trial uses a liquid formulation of larotrectinib (LOXO-101), with dose adjusted by body surface area.

NCT02122913 | Oral TRK Inhibitor Larotrectinib (LOXO-101) for Treatment of Advanced Adult Solid Tumors

Larotrectinib (LOXO-101) is currently being evaluated in an ongoing multicenter, open-label, Phase 1 study in adult subjects with advanced solid tumors that have progressed or are nonresponsive to available therapies and for which no standard or available curative therapy exists.

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For additional information about any of the larotrectinib (LOXO-101) clinical trials, please refer to clinicaltrials.gov.

Interested physicians and patients can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 (1-855-687-5123).

Policy for Access to Investigational Agents

Loxo Oncology is committed to helping patients who have not responded to available therapies and may benefit from its investigational therapies. Loxo Oncology's Policy for Access to Investigational Agents describes the principles and government regulations that the company will follow when considering a request.