LIBRETTO-121: LOXO-292 (Selpercatinib) in Advanced Pediatric Solid & CNS Tumors

Treatment of Oral LOXO-292 (Selpercatinib) in Pediatric Patients with advanced solid tumors

Agents: LOXO-292
Phase I/II
Status Recruiting
Sponsor Loxo Oncology, Inc. (Eli Lilly)

For further information please also consult ClinicalTrials.gov.

 

This is a Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

WHO is the trial for?
  • Patients between 6 months and 21 years with an advanced or metastatic solid/CNS tumor which has failed standard treatment
  • Evidence of an activating RET gene alteration (rearranged during transfection)
  • Overall health status of the patient has to be good

Not eligable: Patients who experienced recent major surgery, cardiac issues, uncontrolled infections, malabsorption, pregnancy, or lactation can not participate.

WHAT is the key question that this trial is attempting to answer?

 This study aims to investigate a drug called LOXO-292. The trial tries to find out whether the drug is effective and safe in the treatment of pediatric participants with an activating RET gene alteration and advanced solid or primary CNS tumors.

WHY patients might want to participate?

 This clinical trial is specifically designed for pediatric participants with an activating RET gene alteration, offering a personalized treatment approach that may directly address the genetic characteristics of their tumor. This trial will further support the research in solid tumors incl. sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in several study centers in Australia, Canada, Denmark, Germany, Italy, Japan, Republic of Korea, Spain, the United Kingdom and the United States.

For further information please check here.

Study contact: 1-877-CTLILLY (1-877-285-4559)/ 1-317-615-4559 or ClinicalTrials.gov@lilly.com

STUDY DESIGN: What does the study look like?

 This study includes 2 parts: Phase 1 (dose escalation) and phase 2 (dose expansion).

In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID).

Once the maximum tolerated dose (MTD) and/or recommended dose is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

The drug is taken orally (by mouth).

HOW do I get more information?

 Patient organizations supporting solid tumors and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving solid tumors and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken