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Tyrosine Kinase Inhibitor
Selpercatinib for Solid Tumors (LIBRETTO-001 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC
Cohorts 1-4 without measurable disease
Must not have
Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib)
Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study)
Awards & highlights
Summary
This trial is testing a new oral drug called selpercatinib in patients with advanced cancers that have specific gene changes. The drug aims to block a gene that helps cancer grow, potentially slowing or stopping the disease.
Who is the study for?
This trial is for people with advanced solid tumors, RET fusion-positive solid tumors, or medullary thyroid cancer who have tried standard treatments without success or can't tolerate them. They must have a life expectancy of at least 3 months and good organ function. People with certain genetic alterations may join only after Sponsor approval. Those who've had recent major surgery, other cancer therapies, or untreated brain metastases are excluded.
What is being tested?
The study tests Selpercatinib (LOXO-292), an oral medication targeting specific genetic changes in tumors. It's given to participants with various types of advanced cancers to assess its safety and how well it works against these cancers.
What are the potential side effects?
While the exact side effects aren't listed here, common ones for drugs like Selpercatinib include fatigue, nausea, liver issues, high blood pressure, dry mouth/skin problems and potential heart rhythm abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is in an early stage, operable, and has not been treated yet.
Select...
My cancer cannot be measured by standard tests.
Select...
My tumor has a RET gene alteration.
Select...
I have at least one tumor that can be measured and hasn't been treated with radiation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 2 weeks.
Select...
I am not taking strong drugs that affect liver enzymes or forbidden medications.
Select...
I haven't had a heart attack in the last 6 months and my heart's electrical cycle is normal.
Select...
I have not had any systemic therapy for my lung cancer.
Select...
I have previously been treated with a RET inhibitor.
Select...
I haven't taken any experimental cancer treatments recently.
Select...
My cancer has a known genetic mutation driving its growth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: MTD
Phase 1: RP2D
Phase 2: Objective Response Rate
Secondary study objectives
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)
Phase 1: Number of Participants with a Treatment-Related Adverse Event(s) (TRAE[s])
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LOXO-292Experimental Treatment1 Intervention
Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific molecular pathways critical for tumor growth and survival. For instance, Selpercatinib is a RET inhibitor that targets RET fusion-positive tumors by blocking the RET kinase activity, thereby inhibiting tumor cell proliferation and survival.
Similarly, other targeted therapies include EGFR inhibitors (e.g., osimertinib, erlotinib) that block the epidermal growth factor receptor, and ALK inhibitors (e.g., crizotinib) that target the anaplastic lymphoma kinase. These treatments are crucial for NSCLC patients as they offer a more personalized approach, leading to better efficacy and potentially fewer side effects compared to traditional chemotherapy.
By targeting specific genetic mutations or alterations, these therapies can significantly improve outcomes and quality of life for patients with advanced NSCLC.
Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.
Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.
Find a Location
Who is running the clinical trial?
Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,204 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,653 Previous Clinical Trials
3,223,649 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,376 Previous Clinical Trials
422,253 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 2 weeks.I am not taking strong drugs that affect liver enzymes or forbidden medications.I don't have severe side effects from past treatments, except for hair loss or mild nerve pain from platinum-based therapy.My lung cancer is in an early stage, operable, and has not been treated yet.I haven't had a heart attack in the last 6 months and my heart's electrical cycle is normal.My cancer does not initially need a RET gene alteration, but will require it after initial treatment.You have a disease that can be measured by specific guidelines for your type of tumor.You are expected to live for at least 3 more months.My blood, liver, and kidney functions are all within normal ranges.I stopped a RET inhibitor treatment but may join with approval.My cancer cannot be measured by standard tests.I have not had any systemic therapy for my lung cancer.My cancer has worsened despite treatment, or I can't tolerate/decline standard treatments.I have previously been treated with drugs targeting multiple kinases including RET.I can care for myself and remain up and about more than half of my waking hours.I've had targeted radiation for symptom relief recently, but not on over 30% of my bone marrow or a wide area.My brain or spinal cancer symptoms are stable, and I haven't had surgery or radiation recently.I have tried or am not suited for standard treatments for my cancer type and stage.My tumor has a RET gene alteration.My cancer is part of the MTC spectrum or has RET changes, pending approval.I have previously been treated with a RET inhibitor.I haven't taken any experimental cancer treatments recently.My cancer has a known genetic mutation driving its growth.I have at least one tumor that can be measured and hasn't been treated with radiation.You do not fit the specific requirements for participating in Cohorts 3 or 4.
Research Study Groups:
This trial has the following groups:- Group 1: LOXO-292
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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