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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Phase 1 / 2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

This is a Phase 1 / 2, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Not Available
Phase I/II
Adults
Not Available
Not Available
Not Available
International
Vanderbilt University
11-05-2018
Treatment
VICCPHI1873
NCT03157128

Eligibility

12 Years
BOTH
NO
Inclusion Criteria:

Key Inclusion Criteria: For Phase 1 - Patients with a locally advanced or metastatic solid tumor who: - have progressed on or are intolerant to standard therapy, or - no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or - decline standard therapy - Prior MKIs with anti-RET activity are allowed. However, prior treatment with a selective RET inhibitor(s) is prohibited. - A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation. - Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type. - Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) ? 40% (age 470 msec on all 3 ECGs during Screening. - Required treatment with certain strong CYP3A4 inhibitors or inducers.

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