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A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05241834
Recruitment Status : Active, not recruiting
First Posted : February 16, 2022
Last Update Posted : March 27, 2024
Sponsor:
Collaborator:
Loxo Oncology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.

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 no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1A: LOXO-260 Dose Escalation
LOXO-260 administered orally
 Drug: LOXO-260
Oral
Other Name: LY3838915
Experimental: Phase 1B: LOXO-260 Dose Expansion
LOXO-260 administered orally
 Drug: LOXO-260
Oral
Other Name: LY3838915


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. To assess the antitumor activity of LOXO-260: ORR [ Time Frame: Up to approximately 24 months or 2 years ]
    ORR per RECIST 1.1


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
University of California, San Francisco Medical Center
San Francisco, California, United States, 94158
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eli Lilly and Company
Loxo Oncology, Inc.
Investigators
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Study Director: Emin Avsar Loxo Oncology, Inc.
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05241834    
Other Study ID Numbers: LOXO-NGR-21001
J3T-OX-JZTA ( Other Identifier: Eli Lilly and Company )
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Solid tumors with RET alteration
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms