Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04211337 · ClinicalTrials.gov registry record · Phase 3
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
A Phase 3 study of Medullary Thyroid Cancer, sponsored by Loxo Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
- 20
- Study locations
NCT04211337: Active Phase 3 study of Medullary Thyroid Cancer, sponsored by Loxo Oncology.
NCT04211337 is a Phase 3 study of Medullary Thyroid Cancer that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 291 participants, roughly in line with the 296-participant average among 4 other Medullary Thyroid Cancer trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04211337, a Phase 3 study of Medullary Thyroid Cancer, is active but no longer recruiting, sponsored by Loxo Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Cabozantinib
- DRUG Selpercatinib
- DRUG Vandetanib
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- UCLA Hematology/Oncology - Westwood (Building 100) - Los Angeles
- University of California Davis (UC Davis) Comprehensive Cancer Center - Sacramento
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Ohio
- University of Cincinnati Medical Center - Cincinnati
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- University of Pennsylvania Hospital - Philadelphia
- Thomas Jefferson University - Philadelphia
Victoria
- The Alfred Hospital - Melbourne
- Peter MacCallum Cancer Centre - Melbourne
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
What the registry record for NCT04211337 still lists
NCT04211337 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 296-participant average among 4 other Medullary Thyroid Cancer trials with a reported enrollment target.
The record links to 1 condition, with Medullary Thyroid Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib is the first listed.
NCT04211337 names 20 study sites across 14 states, led by California, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04211337 about?
NCT04211337 is a clinical study titled "A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer". 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. ...
What is the current status of trial NCT04211337?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2020-02-11. Estimated completion is 2027-11.
What conditions does trial NCT04211337 study?
This clinical trial studies the following conditions: Medullary Thyroid Cancer.
What interventions are being tested in trial NCT04211337?
The interventions under investigation include: Cabozantinib (DRUG), Selpercatinib (DRUG), Vandetanib (DRUG).
Who is sponsoring clinical trial NCT04211337?
This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04211337 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Medullary Thyroid Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
RECRUITING · Phase 1
-
Natural History Study of Children and Adults With Medullary Thyroid Cancer
RECRUITING
-
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
ACTIVE NOT RECRUITING · Phase 1
-
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02074839 · 291 participants · Phase 1
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
- NCT03769766 · 291 participants · Phase 3
Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
- NCT06563479 · 291 participants · Phase 3
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
- NCT04429542 · 292 participants · Phase 1
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI