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8110 Gatehouse Road, Falls Church, VA 22042

Study of LOXO-101 in Subjects with NTRK Fusion Positive Solid Tumors

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT02576431

Background Information

This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3. Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.

LOXO-101 will be administered at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.

The study will include 8 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or othersimilarly-certified laboratories.
  • Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
  • Subjects must have at least one measurable lesion as defined by RECIST 1.1
  • Meet individual cohort criteria in the study protocol.
  • Additional eligibility criteria can be found in protocol.

    Ineligibility Information

    • Symptomatic or unstable brain metastases. Subjects with primary CNS tumors are eligible.
    • Uncontrolled concurrent malignancy that would limit assessment of efficacy olarotrectinib (LOXO-101).
    • Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular
    • disease or other systemic disease that would limit compliance with study procedures.
    • Unstable cardiovascular disease is defined as:In subjects < age 18, persistent uncontrolled hypertension defined as blood pressure in the 95th percentile or greater despite antihypertensive therapy6. Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation.
    • Pregnancy or lactation.
    • Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or othersimilarly-certified laboratories.
    • Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
    • Subjects must have at least one measurable lesion as defined by RECIST 1.1
    • Meet individual cohort criteria in the study protocol.
    • Additional ineligibility criteria can be found in protocol.

    Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT02576431