LOXO-260 for Thyroid Adenoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Thyroid Adenoma+1 More
LOXO-260 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and efficacy of a new drug, LOXO-260, for treating cancer with a specific genetic mutation. The trial will last up to 2 years, and participants may continue longer if their disease does not worsen.

Eligible Conditions
  • Thyroid Adenoma
  • Carcinoma, Non-Small-Cell Lung

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Thyroid Adenoma

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to approximately 24 months or 2 years

During the first 28-day cycle of LOXO-260 treatment
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
Year 2
Phase 1b: To assess the antitumor activity: Overall response rate (ORR)
To assess the antitumor activity of LOXO-260: ORR
To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260

Trial Safety

Safety Progress

1 of 3

Other trials for Thyroid Adenoma

Trial Design

2 Treatment Groups

Phase 1B: LOXO-260 Dose Expansion
1 of 2
Phase 1A: LOXO-260 Dose Escalation
1 of 2
Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: LOXO-260 · No Placebo Group · Phase 1

Phase 1B: LOXO-260 Dose Expansion
Drug
Experimental Group · 1 Intervention: LOXO-260 · Intervention Types: Drug
Phase 1A: LOXO-260 Dose Escalation
Drug
Experimental Group · 1 Intervention: LOXO-260 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 24 months or 2 years

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
39 Previous Clinical Trials
7,359 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,451 Previous Clinical Trials
3,120,544 Total Patients Enrolled
Emin AvsarStudy DirectorLoxo Oncology, Inc.

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You 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.
You have a solid tumor that is metastatic or locally advanced and/or unresectable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.