| 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. |
| Institution Address (Street) |
| Loxo Oncology-400 Oyster Point Drive |
| Institution City |
| South San Francisco |
| Institution State |
| California |
| Institution ZIP Code |
| 94080 |
| Institution Country |
| 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 |
