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A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC). | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

NCT04760288•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib for adults and vandetanib for adolescents). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have histologically confirmed unresectable locally advanced or metastatic MTC and be a candidate for systemic therapy with SOC MKI.
•Must have received no prior systemic anticancer treatment with MKI therapies for advanced or metastatic MTC.
•Must have radiologically confirmed progressive disease within the last 14 months and at least one of the following:
•1. A MTC-associated symptom and
•2. CLN (Calcitonin) and CEA (carcinoembryonic antigen) level doubling time of less than 24 months.
•Confirmed RET mutation.
•Must be able to swallow an oral medication.
•Must have an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug.
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug and to refrain from donating sperm.

Exclusion Criteria

•Participants who are pregnant or breastfeeding, or intending to become pregnant during the study within 14 days after the final dose of pralsetinib or within 4 months after the final dose of vandetanib or cabozantinib.
•Have disease that is suitable for surgery or radiotherapy administered with curative intent.
•Have been previously treated with any systemic kinase inhibitor therapy regimens, including a selective RET inhibitor, given for recurrent and/or metastatic disease.
•Have received any radiation therapy within 14 days prior to Day 1 of Cycle 1 and any related toxicity must be resolved to Grade 1 or better.
•Participant's tumor has any additional known primary driver alterations other than RET.
•Have known hypersensitivity to pralsetinib, vandetanib, or cabozantinib, or any of their ingredients.
•Have a history of pneumonitis of non-infectious etiology within the last 12 months.
•Have ongoing treatment with chronic immunosuppressants or systemic steroids \>10 mg/day.
•Have any history of hereditary bleeding disorder or any evidence of hematemesis.
•Have had major surgery or invasive dental procedure within 3 weeks prior to Day 1 of Cycle 1.
+12 more criteria

Locations (1)

Hospital Universitario Virgen del Rocio

Seville, Spain

Key Dates

Start Date

November 30, 2023

Primary Completion Date

October 6, 2027

Completion Date

April 12, 2035

Last Updated

January 5, 2024

Conditions

Medullary Thyroid Cancer

Interventions

Pralsetinib

DRUG

Cabozantinib

DRUG

Vandetanib

DRUG

Natural History Study of Children and Adults With Medullary Thyroid Cancer

NCT01660984

Medullary Thyroid Cancer

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RECRUITINGPHASE1/PHASE2

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MelanomaMedullary Thyroid Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

Inclusion Criteria

Exclusion Criteria

Natural History Study of Children and Adults With Medullary Thyroid Cancer

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