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
Effectiveness Progress
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
Safety Progress
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: DrugTrial 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
- Wirth, Lori J., Eric Sherman, Bruce Robinson, Benjamin Solomon, Hyunseok Kang, Jochen Lorch, Francis Worden, et al.. 2020. “Efficacy of Selpercatinib in ret-altered Thyroid Cancers”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2005651.
- Drilon, Alexander, Geoffrey R. Oxnard, Daniel S.W. Tan, Herbert H.F. Loong, Melissa Johnson, Justin Gainor, Caroline E. McCoach, et al.. 2020. “Efficacy of Selpercatinib in ret Fusion–positive Non–small-cell Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2005653.
- Subbiah, Vivek, Justin F. Gainor, Geoffrey R. Oxnard, Daniel S.W. Tan, Dwight H. Owen, Byoung Chul Cho, Herbert H. Loong, et al.. 2021. “Intracranial Efficacy of Selpercatinib in ret Fusion-positive Non–small Cell Lung Cancers on the LIBRETTO-001 Trial”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-0800.
- Subbiah, Vivek, Jürgen Wolf, Bhavana Konda, Hyunseok Kang, Alexander Spira, Jared Weiss, Masayuki Takeda, et al.. 2022. “Tumour-agnostic Efficacy and Safety of Selpercatinib in Patients with RET Fusion-positive Solid Tumours Other Than Lung or Thyroid Tumours (LIBRETTO-001): A Phase 1/2, Open-label, Basket Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00541-1.
- Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. doi: 10.1016/S1470-2045(22)00541-1. Epub 2022 Sep 12.
- Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.
- Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardiere C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.
- 2017. "A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03157128.
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Conditions
Cancer Related
Treatments