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

ClinicalTrials.gov Identifier

NCT02576431

Institution Name

This study is being conducted internationally. Contact the LOXO-101 team thru the Study Contact number to find the site nearest to you.

Full Institution Address

Loxo Oncology-400 Oyster Point Drive South San Francisco California 94080 United States

Institution Website

http://www.loxooncology.com

Additional Institutions

This study is being conducted Internationally. Contact the LOXO-101 team thru the Study Contact number to find the site nearest you

Principal Investigator

Loxo Oncology

Principal Investigator Phone

(855) 687-5123

Principal Investigator Email

kherani@loxooncology.com

Additional Principal Investigators

Please 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.

Study Coordinator Phone

(855) 687-5123

Study Coordinator Email

kherani@loxooncology.com

Study Overview

This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas 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 cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions

Enrollment Information

up to 151 patients

Study Start Date

20151001

Study End Date

20251031

Study Purpose

Determine how well LOXO-101 works to shrink tumors Determine how long LOXO-101 works on tumors Determine how long patients on LOXO-101 for advanced cholangiocarcinoma are surviving To understand the role of NTRK fusions in cholangiocarcinoma

Inclusion Criteria

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 cholangiocarcinoma 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

Have been treated before with cancer therapy which works similarly to LOXO-101 against NTRK fusions. Have spread of cholangiocarcinoma 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 Study

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.

Financial Assistance Available

Yes

---