Abemaciclib for Thyroid Cancer

Overseen By Cristy Miles

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Abemaciclib

Disqualifiers: Pregnancy, Active infections, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or unacceptable toxicity

9 Participants Needed

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

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.

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.

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

Group I: Abemaciclib Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+