Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E)

Arms (1)

1. type

   EXPERIMENTAL

   label

   Treatment (larotrectinib [LOXO-101])

   description

   Patients receive larotrectinib (LOXO-101) PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.

   interventionNames

   1. Procedure: Biopsy Procedure
   2. Procedure: Biospecimen Collection
   3. Procedure: Computed Tomography
   4. Drug: Larotrectinib
   5. Procedure: Magnetic Resonance Imaging

Primary outcomes (1)

1. measure

   Objective Response Rate (ORR)

   timeFrame

   Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

   description

   ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.