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

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
ClinicalTrials.gov Identifier (if applicable)
	NCT02576431
Study Center
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.
Institution Address
	Loxo Oncology-400 Oyster Point Drive
City
	South San Francisco
State
	California
Zip Code
	94080
Website
	http://www.loxooncology.com
List additional Institutions (include address, phone number, and website)
	This study is being conducted Internationally. Contact the LOXO-101 team thru the Study Contact number to find the site nearest you.
Study Contacts
Principal Investigator
	Loxo Oncology
P.I. Phone
	(855) 687-5123
P.I. Email
	kherani@loxooncology.com
List additional Principal Investigators (include phone number and email)
	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
	—
Study Coordinator Phone
	(855) 687-5123
Study Coordinator Email
	kherani@loxooncology.com
OVERVIEW – in layman’s terms (150 words max)
	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
	up to 151 patients
Study Start Date
	10/01/2015
Estimated Completion Date
	10/31/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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 – 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 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 – Patients Must NOT:
	¥ 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 BEGINNING STUDY TREATMENT – in layman’s terms
	¥ 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 – in layman’s terms
	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.