Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03157128
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2017-05-09
Brief Title:
A Study of Selpercatinib LOXO-292 in Participants With Advanced Solid Tumors RET Fusion-Positive Solid Tumors and Medullary Thyroid Cancer LIBRETTO-001
Sponsor:
Loxo Oncology Inc
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 12 Study of Oral Selpercatinib LOXO-292 in Patients With Advanced Solid Tumors Including RET Fusion-Positive Solid Tumors Medullary Thyroid Cancer and Other Tumors With RET Activation LIBRETTO-001
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03906331
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
LIBRETTO-001
Brief Summary:
This is an open-label first-in-human study designed to evaluate the safety tolerability pharmacokinetics PK and preliminary anti-tumor activity of selpercatinib also known as LOXO-292 administered orally to participants with advanced solid tumors including rearranged during transfection RET-fusion-positive solid tumors medullary thyroid cancer MTC and other tumors with RET activation
Detailed Description:
This is an open-label multi-center Phase 12 study in participants with advanced solid tumors including RET fusion-positive solid tumors MTC and other tumors with RET activation The trial will be conducted in 2 parts Phase 1 dose escalation - completed and phase 2 dose expansion Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies or no standard or available curative therapy exists or in the opinion of the Investigator they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy or they declined standard therapy A dose of 160 milligrams mg twice a day BID has been selected as the recommended phase 2 dose RP2D Approximately 875 participants with advanced solid tumors harboring a RET gene alteration in tumor andor blood will be enrolled to one of seven phase 2 cohorts
Cohort 1 Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy open
Cohort 2 Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants open
Cohort 3 Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy closed
Cohort 4 Advanced RET-mutant MTC participants who are treatment naïve closed
Cohort 5 Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors eg pheochromocytoma otherwise ineligible for cohorts 1-4 See details in inclusionexclusion criteria open
Cohort 6 Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval closed
Cohort 7 RET fusion positive early-stage non-small cell lung cancer NSCLC participants who are candidates for definitive surgery Participants will receive selpercatinib in a neoadjuvant and adjuvant setting Participants will be followed for disease recurrence for up to 5 years from the date of surgery closed
Cohort 1 Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy open
Cohort 2 Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants open
Cohort 3 Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy closed
Cohort 4 Advanced RET-mutant MTC participants who are treatment naïve closed
Cohort 5 Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors eg pheochromocytoma otherwise ineligible for cohorts 1-4 See details in inclusionexclusion criteria open
Cohort 6 Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval closed
Cohort 7 RET fusion positive early-stage non-small cell lung cancer NSCLC participants who are candidates for definitive surgery Participants will receive selpercatinib in a neoadjuvant and adjuvant setting Participants will be followed for disease recurrence for up to 5 years from the date of surgery closed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000800-59 | EUDRACT_NUMBER | Loxo Oncology Inc | None |
| J2G-OX-JZJA | OTHER | None | None |
| LOXO-RET-17001 | OTHER | None | None |