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Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

NCT04552769•Stanford University

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the efficacy of treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid

Detailed Description

Primary Objective The primary objective is to determine the overall response rate after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer. Secondary Objectives The secondary objectives are to describe the overall survival (OS) and progression-free survival (PFS) after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer.Safety assessments of AE's will also be analysed

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* Unresectable anaplastic thyroid cancer limited to the neck: Patients must have received radiation therapy or surgery to primary tumor and have subsequent evidence of anaplastic thyroid cancer (ATC).
•* Metastatic anaplastic thyroid cancer: either with entirely surgically removed cancer/metastatic only disease, or with disease in the neck not requiring radiation or surgery to the neck mass.
•3. Patients with a bulky thyroid/neck mass and those in whom airway obstruction is suspected should undergo an evaluation via indirect or direct laryngoscopy to ensure patency of the trachea/airway prior to enrollment
•4. Patients will not have any other curative therapeutic option, such as radiation or surgery.
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
•6. Have measurable disease based on RECIST 1.1
•7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived sample.
•8. Be ≥ 18 years of age on day of signing informed consent.
•9. Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to study treatment start. A washout period of at least 21 days is required between last chemotherapy dose and study treatment start (provided the patient did not receive radiotherapy).
•10. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and study treatment start.
+7 more criteria

Exclusion Criteria

•1. Patients with known hypersensitivity to any of the excipients of abemaciclib
•2. History of carcinomatous meningitis
•3. Prior therapy with abemaciclib.
•4. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
•5. Females who are pregnant or lactating.
•6. The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
•7. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
•8. Presence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

September 10, 2020

Primary Completion Date

April 12, 2023

Completion Date

January 5, 2025

Last Updated

June 5, 2025

Enrollment

ACTUAL participants

Conditions

Thyroid CancerAnaplastic Thyroid CancerUndifferentiated Thyroid Cancer

Interventions

Abemaciclib

DRUG

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

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RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514

Thyroid CancerCancer of the Thyroid

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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: June 5, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

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Adjuvant Radiotherapy in High Risk Locally Advanced DTC

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Natural History Study of Children and Adults With Medullary Thyroid Cancer