LOXO-292 for Colon Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colon Cancer+3 MoreLOXO-292 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the effects of a new drug, selpercatinib, on various types of solid tumors. The goal is to see if it is safe and tolerable, how it is metabolized, and if it has any preliminary anti-tumor activity.

Eligible Conditions
  • Colon Cancer
  • Non-Small Cell Lung Cancer
  • Solid Tumor
  • Medullary Thyroid Cancer

Treatment Effectiveness

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Cycle 1 Day 1 through Cycle 5 Day 1 (Cycle = 28 days)

Year 2
Phase 1: Overall Response Rate (ORR) based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)
Phase 2: CBR (by IRC and Investigator)
Phase 2: CNS DOR (by IRC)
Phase 2: Central Nervous System (CNS) ORR (by IRC)
Phase 2: Duration of Response (DOR; by IRC and Investigator)
Phase 2: ORR (by Investigator)
Phase 2: Overall Survival (OS)
Phase 2: PFS (by IRC and Investigator)
Year 2
Phase 2: Objective Response Rate
Day 28
Phase 1 and 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)
Phase 1 and 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
Month 24
Phase 1: Number of Participants with a Treatment-Related Adverse Event(s) (TRAE[s])
Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)
Phase 2: Percentage of Participants with any Serious Adverse Event (SAE[s])
Day 28
Phase 1: MTD
Month 12
Phase 1: RP2D
Year 2
Phase 2: Time to Any and Best Response (by IRC and Investigator)

Trial Safety

Trial Design

1 Treatment Group

LOXO-292
1 of 1

Experimental Treatment

875 Total Participants · 1 Treatment Group

Primary Treatment: LOXO-292 · No Placebo Group · Phase 1 & 2

LOXO-292
Drug
Experimental Group · 1 Intervention: LOXO-292 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 day 1 through cycle 5 day 1 (cycle = 28 days)

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,467 Previous Clinical Trials
3,134,682 Total Patients Enrolled
Loxo Oncology, Inc.Lead Sponsor
41 Previous Clinical Trials
6,668 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,259 Previous Clinical Trials
368,678 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Measurable or non-measurable disease as determined by RECIST 1.
Participants must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
You are eligible if you have a RET gene alteration in tumor and at least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated.
References