A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
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|ClinicalTrials.gov Identifier: NCT05241834|
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : April 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Thyroid Neoplasms||Drug: LOXO-260||Phase 1|
Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Oral LOXO-260 in Patients With RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors|
|Actual Study Start Date :||March 23, 2022|
|Estimated Primary Completion Date :||April 2026|
|Estimated Study Completion Date :||April 2026|
Experimental: Phase 1A: LOXO-260 Dose Escalation
LOXO-260 administered orally
Other Name: LY3838915
Experimental: Phase 1B: LOXO-260 Dose Expansion
LOXO-260 administered orally
Other Name: LY3838915
- Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate [ Time Frame: During the first 28-day cycle of LOXO-260 treatment ]DLT rate
- Phase 1b: To assess the antitumor activity: Overall response rate (ORR) [ Time Frame: Up to approximately 24 months or 2 years ]ORR per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
- To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260 [ Time Frame: Up to approximately 24 months or 2 years ]PK: Mean concentration of LOXO-260
- To assess the antitumor activity of LOXO-260: ORR [ Time Frame: Up to approximately 24 months or 2 years ]ORR per RECIST 1.1
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|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must be ≥ 18 years of age at the time of signing the informed consent (Phase 1a and Phase 1b). Patients 12 years and older may be enrolled in Phase 1b for countries and sites where approved.
- Must have evidence of a previously documented RET fusion (solid tumors) or RET mutation (MTC or MEN2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria.
- Have received a prior selective RET inhibitor.
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 (age > 16 years), Karnofsky Performance Status (KPS) ≥ 80 (age > 16 years), or Lansky Performance Status (LPS) ≥ 40% (age < 16 years).
- 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.
- Have adequate organ function.
- Phase 1b expansion: Patients must have measurable disease per RECIST v 1.1.
- Phase 1b expansion: Molecular Pathology Results (including RET and other genes) from a sample, blood or tissue, taken on or after RET selective treatment.
- Disease suitable for local therapy administered with curative intent.
- Have an active fungal, bacterial, and/or active untreated viral infection.
- The patient has a serious pre-existing medical condition(s).
- Have symptomatic CNS malignancy or metastasis.
- Patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 3A (CYP3A).
- Progression of disease within 4 months of starting a prior selective RET inhibitor.
- Phase 1b expansion: Patients harboring known activating bypass alterations outside RET that may confer resistance to LOXO-260.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05241834
|Contact: Patient Advocacyfirstname.lastname@example.org|
|United States, California|
|UCLA Medical Center||Recruiting|
|Los Angeles, California, United States, 90095|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago Medicine-Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|Sarah Cannon Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Emin Avsar||Loxo Oncology, Inc.|
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
J3T-OX-JZTA ( Other Identifier: Eli Lilly and Company )
|First Posted:||February 16, 2022 Key Record Dates|
|Last Update Posted:||April 10, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Solid tumors with RET alteration
Carcinoma, Non-Small-Cell Lung
Endocrine System Diseases
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms