Clinical Trial VICCMD15110
A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors
- Protocol No. VICCMD15110
- Open Date: 04/05/2016
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: To determine the overall response rate (ORR) as measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or Response Assessment in Neuro-Oncology (RANO) criteria, as appropriate, following treatment with LOXO-101 in adult subjects with an advanced cancer harboring a fusion involving NTRK1, NTRK2, or NTRK3 (collective referred to as NTRK fusions) for each tumor-specific disease cohort.
- Disease Sites: Head/Neck; Neuro-Oncology; Miscellaneous; Sarcoma; Colon; Rectal; Thyroid; Liver; Lung
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: LOXO-101
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT02576431
- Secondary Protocol No: LOXO-TRK-15002
|Ages Eligible for Study:||12 Years and older|
|Genders Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
1. Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
2. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
3. Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 upper limit of normal (ULN), or AST and ALT < 5 ULN if liver function abnormalities are due to underlying malignancy.
• Total bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
• Serum creatinine < 2.0 ULN OR an estimated glomerular filtration rate ≥ 30 mL/minute using the Cockroft-Gault formula.
Key Exclusion Criteria:
1. Pregnancy or lactation.