Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors

Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors

Sarcoma

Active, not recruiting

2

Start Date 09/30/2015

Age of Trial (yrs) 9.2

Gleevec-resistant

TRK Inhibitor

Block related tumor signal paths

GIST not specified. GIST patient enrollment unknown.

LOXO-TRK-15002

Bayer

Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Oral

In the US this trial is currently recruiting only at MD Anderson in Texas.

Detailed Description:

This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3. Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.

LOXO-101 will be administered at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.

The study will include 8 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.

Incusion Criteria:

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.

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.

Subjects must have at least one measurable lesion as defined by RECIST 1.