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

STUDY NAME:

“Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors”

Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.

CT.GOV IDENTIFIER

NCT02576431

STUDY CENTERS:

This study is being conducted Internationally.

Contact the LOXO-101 team thru the Study Contact number to find the site nearest you.

STUDY CONTACT:

Loxo Oncology

1-855-NTRK-123

If the representative is not answering when you call, please leave your contact information and your call will be returned within 1 day.

OVERVIEW:

This phase 2 study will enroll patients of all tumor types, including sarcomas, who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the sarcoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions in these cancers. This study will measure how well and for how long LOXO-101 works. Patients with a sarcoma who would not be able to receive any other options for treatment can participate in this trial. If you are not sure if your cancer has one of these NTRK fusions, talk to your doctor about available options to have your tumor tissue tested.

Inclusion Criteria – Patients must:

Have a diagnosis of a solid tumor cancer (not a leukemia or lymphoma) which is locally aggressive or has spread to other parts of the body.
Have the NTRK1, NTRK2, or NTRK3 gene fusion abnormality within the cancer as identified when performed at a CLIA or similarly certified laboratories.
Have received prior standard therapy appropriate for their stage of sarcoma or, in the opinion of their doctor, would be unlikely to tolerate or derive clinical benefit from any other standard of care therapy.
Have completed prior radiation more than 12 weeks before the planned start of study drug therapy.
Have either at least one “measurable lesion” on a CT or MRI scan OR not have a “measurable lesion” but have some findings related to their cancer which can be evaluated while on the study drug (fluid collections, cancer spread to the bone, for example).
Have good liver and kidney organ function on blood tests.
Have the ability to swallow capsules.

EXCLUSION CRITERIA- Patients must NOT:

Have been treated before with cancer therapy which works similarly to LOXO-101 against NTRK fusions.
Have spread of their tumor (sarcoma) to the brain which is causing symptoms or making the patient’s overall health unstable. If tumor has involved the brain but is stable then patients may be considered for the study.
Be pregnant or breast feeding.

REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT

The study team will need to get a sample of your tumor taken from a previous surgery or biopsy
A new biopsy will be done to take a small sample of tumor after you sign the consent form to take part in the study and in the few days before the study treatment starts
Blood tests to measure your liver and kidney function
A heart rhythm tracing (EKG)
A CT or MRI scan to measure your tumor if not done within 30 days of starting the study therapy

POTENTIAL SIDE-EFFECTS
The most common side effects observed in > 10 % of patients have been: constipation, nausea, abdominal pain, diarrhea, dry mouth, vomiting, fatigue, elevation of liver tests, joint pain, dizziness, and rash.

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