9 Participants Needed

Abemaciclib for Thyroid Cancer

CM
Overseen ByCristy Miles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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

Research Team

SA

Saad A Khan, MD

Principal Investigator

Stanford Universiy

Eligibility Criteria

This trial is for adults with advanced anaplastic or undifferentiated thyroid cancer that can't be cured by surgery or radiation. Participants must have acceptable organ function, not be pregnant, and agree to use contraception. They should not have other serious medical conditions, a history of certain heart issues, or active infections.

Inclusion Criteria

I have had my airway checked for blockages due to a large thyroid or neck mass.
Have measurable disease based on RECIST 1.1
I agree to provide a recent biopsy of my tumor.
See 12 more

Exclusion Criteria

I do not have any ongoing serious infections.
Patients with known hypersensitivity to any of the excipients of abemaciclib
I am not pregnant or breastfeeding.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib twice daily in 28-day cycles until progression or unacceptable toxicity develops

Until progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

3 years

Treatment Details

Interventions

  • Abemaciclib
Trial Overview The study tests the effectiveness of abemaciclib in treating advanced thyroid cancer. Patients will take this oral medication and their response to treatment will be monitored according to specific health criteria outlined in the study design.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AbemaciclibExperimental Treatment1 Intervention
Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Verzenio for:
  • Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer
🇪🇺
Approved in European Union as Verzenio for:
  • HR+, HER2- advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+
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