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 is Eligible

• Genders:
  • Men
  • 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

[email protected]

Phone

-7748

Principal Investigator

Stefan Charles Grant, MD, JD, MBA