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A Phase 1 Study of Oral LOXO-292 in Patients With Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, and Other Tumors With Increased RET Activity

Status
Active
Cancer Type
Colon/Rectal Cancer
Lung Cancer
Skin Cancer (Non-Melanoma)
Thyroid Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03157128
Protocol IDs
LOXO-RET-17001 (primary)
NCI-2017-00976
2017-000800-59
Study Sponsor
Loxo Oncology, Inc.

Summary

This is a Phase 1, 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 non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors with increased RET activity.

Objectives

The trial will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2). During Part 1, patients with advanced NSCLC, advanced MTC or other advanced solid tumors are initially eligible if the tumor has progressed following or has not adequately responded to standard therapy, or if the patient is intolerant of, unlikely to benefit from or refuses standard therapy. During Part 2, patients with NSCLC, MTC or other advanced solid tumor that harbors a RET gene alteration or other evidence of increased RET activity are eligible.
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