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A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment

Status
Closed
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05241834
Protocol IDs
LOXO-NGR-21001 (primary)
NCI-2022-01823
J3T-OX-JZTA
Study Sponsor
Eli Lilly and Company

Summary

The main purpose of this study is to learn more about the safety, side effects, and
effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a
particular gene (known as the RET gene). Participation could last up to 24 months (2 years)
and possibly longer if the disease does not get worse.

Eligibility

  1. Must be = 18 years of age at the time of signing the informed consent (Phase 1a and Phase 1b). Patients 12 years and older may be enrolled in Phase 1b for countries and sites where approved.
  2. Must have evidence of a previously documented RET fusion (solid tumors) or RET mutation (MTC or MEN2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria.
  3. Have received a prior selective RET inhibitor.
  4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 (age > 16 years), Karnofsky Performance Status (KPS) = 80 (age > 16 years), or Lansky Performance Status (LPS) = 40% (age < 16 years).
  5. Have discontinued all previous treatments for cancer with resolution of any significant AEs, and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy.
  6. Have adequate organ function.
  7. Phase 1b expansion: Patients must have measurable disease per RECIST v 1.1.
  8. Phase 1b expansion: Molecular Pathology Results (including RET and other genes) from a sample, blood or tissue, taken on or after RET selective treatment.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.