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Protocol # 22-124

Status

Recruiting

Description

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.

Condition

  • Carcinoma, Non-Small-Cell Lung
  • Thyroid Neoplasms

Interventions

  • LOXO-260

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate

Secondary Outcome:

  • Phase 1b: To assess the antitumor activity: Overall response rate (ORR)
  • To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260
  • To assess the antitumor activity of LOXO-260: ORR

Enrollment

140

Study Start Date

March 23, 2022

Eligibility

  • Gender:     All
  • Minimum age:     12 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Eli Lilly and Company

Source

Eli Lilly and Company

Official title

A Phase 1 Study of Oral LOXO-260 in Patients With RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors

Clinicaltrials.gov Identifier

NCT05241834

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.