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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of abemaciclib for individuals with certain types of advanced thyroid cancer, specifically anaplastic or undifferentiated thyroid cancer. Abemaciclib, a cancer treatment drug, is administered in cycles to determine its ability to control the cancer. Suitable participants have thyroid cancer that is no longer treatable with surgery or radiation and lacks a specific genetic mutation, unless they have already tried other treatments for it. Participants must be able to swallow pills and have no other treatment options. The trial will continue until the cancer progresses or the treatment causes unacceptable side effects. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, there is a required 'washout period' of at least 21 days after your last chemotherapy dose and 14 days after radiotherapy before starting the study treatment.

Is there any evidence suggesting that abemaciclib is likely to be safe for humans?

Research has shown that abemaciclib holds promise as a treatment, particularly for thyroid cancer. In studies involving patients with advanced breast cancer, it proved relatively safe. For example, when combined with other treatments, abemaciclib reduced the risk of cancer spreading by about 30%, indicating it is generally well-tolerated by these patients.

In another study with patients who have metastatic breast cancer, abemaciclib was combined with fulvestrant (another cancer drug). This combination appeared effective and safe. Although abemaciclib is still under investigation for thyroid cancer, its use in breast cancer patients suggests it might be safe for other cancer types as well.

The trial phase involves researchers collecting detailed safety information for abemaciclib in thyroid cancer, but earlier results in other cancers provide some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for thyroid cancer?

Abemaciclib is unique because it targets specific proteins called cyclin-dependent kinases (CDK4 and CDK6), which play a key role in cell division and cancer growth. Unlike standard treatments for thyroid cancer, such as surgery, radioactive iodine, or traditional chemotherapy, Abemaciclib specifically inhibits these kinases, potentially reducing the growth of cancer cells while sparing healthy ones. Researchers are excited about its potential to offer a more targeted therapy with possibly fewer side effects compared to conventional treatments.

What evidence suggests that abemaciclib might be an effective treatment for thyroid cancer?

Previous studies have shown that abemaciclib holds promise in treating certain types of cancer. For patients with anaplastic thyroid cancer, traditional treatments typically resulted in a survival time of just 3-4 months. This trial will evaluate abemaciclib, which aims to improve these outcomes by specifically targeting cancer growth. Research suggests it may slow the disease, potentially extending survival. While more information exists on its use in other cancers, such as breast cancer, early signs indicate abemaciclib could also be a promising option for thyroid cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Saad A Khan, MD

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

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 agree to use birth control during and for 3 months after the study.

Have measurable disease based on RECIST 1.1

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other procedures

Exclusion Criteria

Patients with known hypersensitivity to any of the excipients of abemaciclib

I do not have any ongoing serious infections.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301624002281

Phase II trial of Abemaciclib in Unresectable or Metastatic ...

Results. Nine patients received abemaciclib. Baseline demographics: median age of 73, 66% female gender. Median treatment duration on abemaciclib was 8 weeks ( ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS6112

Abemaciclib in metastatic or locally advanced anaplastic ...

In the pre-molecular era, treatment options were largely ineffective, reflected in a median overall survival of 3-4 months following diagnosis.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04552769

Abemaciclib in Metastatic or Locally Advanced Anaplastic ...

Primary Objective The primary objective is to determine the overall response rate after treatment with abemaciclib in patients with anaplastic ...

4.

curetoday.com

curetoday.com/view/verzenio-plus-endocrine-therapy-benefits-survival-for-some-with-breast-cancer

Verzenio Plus Endocrine Therapy Benefits Survival for ...

There were 301 OS events in the Verzenio arm versus 360 in the endocrine therapy–alone arm. The OS rates at 60, 72 and 84 months were 91.2%, ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37653504/

metastatic or advanced breast cancer patients: a network ...

Abemaciclib plus fulvestrant or ribociclib plus AI appear to be effective and relatively safe for the treatment of HR+/HER2- metastatic or advanced BC patients.

6.

targetedonc.com

targetedonc.com/view/sustained-abemaciclib-benefit-in-high-risk-breast-cancer-monarche-trial-update

Sustained Abemaciclib Benefit in High-Risk Breast Cancer

The data shows a approximately 30% reduction in the number of patients developing metastatic disease with the addition of abemaciclib. This ...