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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04211337
Registration number
NCT04211337
Ethics application status
Date submitted
24/12/2019
Date registered
26/12/2019
Titles & IDs
Public title
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
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Scientific title
A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)
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Secondary ID [1]
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J2G-MC-JZJB
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Secondary ID [2]
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17478
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Universal Trial Number (UTN)
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Trial acronym
LIBRETTO-531
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medullary Thyroid Cancer
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Condition category
Condition code
Cancer
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Thyroid
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Cancer
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Neuroendocrine tumour (NET)
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Metabolic and Endocrine
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0
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Selpercatinib
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Vandetanib
Experimental: Selpercatinib - Treatment A (TRT A) - 160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
Active comparator: Cabozantinib or Vandetanib - Treatment B (TRT B) - 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* =1.6 - 200 QD
Treatment: Drugs: Selpercatinib
Administered orally
Treatment: Drugs: Cabozantinib
Administered orally
Treatment: Drugs: Vandetanib
Administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
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Assessment method [1]
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PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria, or death from any cause in the absence of BICR-documented progressive disease.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [1]
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Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 35 Months
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Secondary outcome [1]
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Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
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Assessment method [1]
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TFFS by BICR is defined as the time from randomization to the first occurrence of:
* documented radiographic disease progression per RECIST 1.1 as assessed by BICR; or
* unacceptable toxicity leading to treatment discontinuation as assessed by the investigator.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
To qualify as an event, the toxicity must be from an intolerable AE (defined as any study drug-related AE that meets protocol guidance for treatment discontinuation, with the exception of alopecia); or death (due to any cause).
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Timepoint [1]
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Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 35 Months
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Secondary outcome [2]
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Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR
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Assessment method [2]
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ORR is defined as the number of participants who achieved the best overall response (BOR) of CR or PR divided by the total number of participants randomized to each treatment arm. ORR per RECIST 1.1 as assessed by BICR.
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Timepoint [2]
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Baseline through Disease Progression or Death up to 35 months
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Secondary outcome [3]
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Duration of Response (DoR) by BICR
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Assessment method [3]
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DoR by BICR is defined as the time from the date that measurement criteria for complete response (CR) or partial response (PR) (whichever is first recorded) are first met by the BICR or investigator assessment, as applicable, until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [3]
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Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 33 Months
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall survival (OS) is defined as the time from randomization until death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.
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Timepoint [4]
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Baseline to Date of Death from Any Cause Up to 36 Months
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Secondary outcome [5]
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PFS2 by Investigator
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Assessment method [5]
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Progression-free survival 2 (PFS2) is defined as the time from randomization to disease progression (radiographic or symptomatic progression as determined by the investigator) on the next line of treatment or death from any cause in the absence of observed disease progression. If the participant is alive at the cutoff for analysis, and disease progression has not been observed, PFS2 data will be censored on the latest date of last progression-free assessment or start of the next line of treatment.
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Timepoint [5]
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Baseline to Second Disease Progression or Death from Any Cause Up to 35 Months
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Secondary outcome [6]
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Comparative Tolerability: Number of Weeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
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Assessment method [6]
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Comparative tolerability defined as a comparison of the proportion of time on treatment with high side effect bother as assessed by the FACT-GP5. The FACT-GP5 is a single question used to assess the overall bother of the treatment side effects. It is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bother from treatment side effects.
Time with high side effect bother (i.e.) score of 3 or 4 is reported here and was derived as follows: cumulative amount of time, in weeks, during which a participant reports high side effect bother divided by the total duration of therapy (weeks), derived as (date of last study treatment dose - date of first study treatment dose + 1) divided by 7.
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Timepoint [6]
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Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 35 Months
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Secondary outcome [7]
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The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants With RET-Positive Specimens as Called by the Central Lab, Which is Also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
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Assessment method [7]
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Timepoint [7]
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Baseline
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Eligibility
Key inclusion criteria
* At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
* Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
* Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Participants with measurable or non-measurable but evaluable disease are eligible; however, participants with non-measurable disease may not have disease limited to bone sites only.
* A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
* Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status
* Eastern Cooperative Oncology Group performance status score of 0 to 2.
* Adequate hematologic, hepatic, and renal function and electrolytes.
* Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
* Ability to swallow capsules.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
* Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm are ineligible if QTcF is >450 milliseconds.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
* Active hemorrhage or at significant risk for hemorrhage.
* Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed =2 years previously and not currently active. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
291
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment outside Australia
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Alabama
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Liège
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Spain
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Girona [Gerona]
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Spain
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Madrid, Comunidad De
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Spain
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Málaga
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Zaragoza
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United Kingdom
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Cardiff [Caerdydd Gb-crd]
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United Kingdom
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England
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United Kingdom
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Glasgow City
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United Kingdom
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Kensington And Chelsea
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United Kingdom
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London, City Of
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Loxo Oncology, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Eli Lilly and Company
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
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Trial website
https://clinicaltrials.gov/study/NCT04211337
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Trial related presentations / publications
Wirth LJ, Brose MS, Elisei R, Capdevila J, Hoff AO, Hu MI, Tahara M, Robinson B, Gao M, Xia M, Maeda P, Sherman E. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naive RET-mutant medullary thyroid cancer. Future Oncol. 2022 Sep;18(28):3143-3150. doi: 10.2217/fon-2022-0657. Epub 2022 Aug 15. Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662.
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/37/NCT04211337/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/37/NCT04211337/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04211337