A Study to Evaluate How Well Certain Types of Cancer Respond to an Investigational Drug (LOXO-101)

What we are studying

This research study is being done to see if, and how well, your type of cancer responds to the investigational drug called LOXO-101. You must have an alteration (change) in a particular gene called NTRK1, NTRK2 or NTRK3 within your cancer in order to participate in this study. LOXO-101 is an oral investigational (or experimental) drug that blocks the actions of the NTRK genes in cancer cells and may be useful to treat cancer. In this study, LOXO-101 will be studied in 8 different groups of subjects (called cohorts) determined by cancer type. Type of Cancer: Non-small Cell Lung, Thyroid, Sarcoma, Colon (Colorectal), Salivary, Biliary, Primary CNS, Other Solid Tumors

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Must have received prior standard therapy
  • Must have at least one measurable lesion
  • Must be able to swallow capsules
  • Can not have active uncontrolled systemic bacterial; viral; or fungal infection or unstable cardiovascular disease
  • Can not have Malabsorption syndrome or other condition affecting oral absorption
  • Cannot be pregnant or nursing

What is involved

  • Physical exam
  • Blood draws
  • Urine samples
  • Pregnancy test
  • Cancer tissue biopsy
  • CT scan or CT-PET scans
  • MRI or CT of brain
  • EORTC QLQ-C30 and EQ-5D
  • ECOG
  • Whole blood for genomic DNA analysis
  • ECG
  • Administration of test drug

Compensation

Travel expenses may be reimbursed. A travel service will also be made available to you and a companion caregiver if needed. This service is offered to you to reduce your out-of-pocket expenses.

Contact Information

Study Coordinator
Sharon Averill, RN
Email
saverill@wakehealth.edu
Phone
336-713-7748
Principal Investigator
Stefan Charles Grant, MD, JD, MBA

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.